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https://www.raps.org/news-and-articles/rf-quarterly/2023-q4 2025-05-06T11:44:41-04:00 https://www.raps.org/resources/suppliers-guide/bsi-group-america-inc 2023-04-04T00:51:21-04:00 https://www.raps.org/certifications/rac/raps-certification-and-certificate-portfolio 2025-04-08T10:19:23-04:00 https://www.raps.org/news-and-articles/rf-quarterly/2023-q3 2025-05-06T11:02:06-04:00 https://www.raps.org/certifications/rac/exam-overview 2023-08-30T09:27:36-04:00 https://www.raps.org/news-and-articles/rf-quarterly/2023-q2 2025-05-05T17:03:59-04:00 https://www.raps.org/resources/suppliers-guide/celegence 2024-01-09T12:15:45-05:00 https://www.raps.org/certifications/rac/faq 2023-08-28T11:15:48-04:00 https://www.raps.org/news-and-articles/rf-quarterly/2023-q1 2025-05-05T16:16:34-04:00 https://www.raps.org/resources/suppliers-guide/cencora-pharmalex 2024-05-20T10:46:00-04:00 https://www.raps.org/certifications/rac/rac-prep-tools 2026-02-03T10:12:03-05:00 https://www.raps.org/news-and-articles/rf-quarterly/2022-q4 2024-06-06T13:29:26-04:00 https://www.raps.org/resources/suppliers-guide/certara 2023-04-21T13:49:10-04:00 https://www.raps.org/news-and-articles/rf-quarterly/2022-q3 2024-06-07T13:28:00-04:00 https://www.raps.org/news-and-articles/rf-quarterly/2022-q2 2024-06-07T13:21:17-04:00 https://www.raps.org/news-and-articles/rf-quarterly/2022-q1 2024-06-07T13:10:11-04:00 https://www.raps.org/news-and-articles/rf-quarterly/2021-q4 2024-06-07T12:46:00-04:00 https://www.raps.org/resources/suppliers-guide/dekra-certification 2023-04-26T12:20:48-04:00 https://www.raps.org/news-and-articles/rf-quarterly/2021-q3 2024-06-07T12:06:01-04:00 https://www.raps.org/news-and-articles/rf-quarterly/2021-q2 2024-06-07T11:50:11-04:00 https://www.raps.org/resources/suppliers-guide/dqs-inc 2023-09-27T15:50:41-04:00 https://www.raps.org/news-and-articles/rf-quarterly/2021-q1 2024-06-07T09:56:17-04:00 https://www.raps.org/news-and-articles/rf-quarterly/rf-article-series-2020-q4 2023-04-19T12:29:34-04:00 https://www.raps.org/resources/suppliers-guide/evidera 2023-04-21T13:57:17-04:00 https://www.raps.org/resources/suppliers-guide/evnia 2023-04-04T01:08:36-04:00 https://www.raps.org/resources/suppliers-guide/fang-consulting-ltd 2023-04-04T01:09:38-04:00 https://www.raps.org/resources/suppliers-guide/g-l-healthcare-advisors 2023-09-27T15:42:08-04:00 https://www.raps.org/resources/suppliers-guide/gl-scientific-inc 2023-04-04T01:11:07-04:00 https://www.raps.org/resources/suppliers-guide/hartmannwillner-llc 2023-04-04T01:11:29-04:00 https://www.raps.org/resources/suppliers-guide/hughes-biopharma-advisers-llc 2023-10-02T13:47:59-04:00 https://www.raps.org/resources/suppliers-guide/icon 2023-05-11T13:54:19-04:00 https://www.raps.org/resources/suppliers-guide/innovatum-inc 2023-04-04T01:12:14-04:00 https://www.raps.org/resources/suppliers-guide/isaca 2024-03-19T10:47:38-04:00 https://www.raps.org/resources/suppliers-guide/kivo 2024-11-18T09:51:59-05:00 https://www.raps.org/resources/suppliers-guide/lachman-consultant-services-inc 2023-05-24T18:42:26-04:00 https://www.raps.org/resources/suppliers-guide/lindsey-regulatory-affairs-consulting-llc 2023-04-04T13:03:29-04:00 https://www.raps.org/resources/suppliers-guide/mcra 2023-04-04T01:16:15-04:00 https://www.raps.org/resources/suppliers-guide/mdss-gmbh 2024-09-12T13:35:58-04:00 https://www.raps.org/resources/suppliers-guide/medenvoy-global 2023-04-04T12:40:15-04:00 https://www.raps.org/resources/suppliers-guide/namsa 2023-04-21T15:54:16-04:00 https://www.raps.org/resources/suppliers-guide/navitas-life-sciences 2025-12-09T12:37:07-05:00 https://www.raps.org/resources/suppliers-guide/network-partners 2023-04-04T01:20:30-04:00 https://www.raps.org/resources/suppliers-guide/nsf 2024-09-30T08:07:01-04:00 https://www.raps.org/resources/suppliers-guide/octane 2025-02-12T13:21:53-05:00 https://www.raps.org/resources/suppliers-guide/opus-regulatory-inc 2023-04-04T01:20:45-04:00 https://www.raps.org/resources/suppliers-guide/pacific-bridge-medical 2023-04-04T01:23:00-04:00 https://www.raps.org/resources/suppliers-guide/pharmaknowl 2025-10-15T12:35:09-04:00 https://www.raps.org/resources/suppliers-guide/pharmavoice 2023-03-24T21:41:51-04:00 https://www.raps.org/resources/suppliers-guide/pilgrim-quality-solutions 2023-04-04T01:26:14-04:00 https://www.raps.org/resources/suppliers-guide/power-office 2025-10-21T14:57:14-04:00 https://www.raps.org/resources/suppliers-guide/productlife-group 2024-06-27T10:00:39-04:00 https://www.raps.org/resources/suppliers-guide/psc-biotech 2023-04-04T01:28:02-04:00 https://www.raps.org/resources/suppliers-guide/qbd-group 2024-10-11T09:07:54-04:00 https://www.raps.org/resources/suppliers-guide/qualira-inc 2025-09-03T13:45:17-04:00 https://www.raps.org/resources/suppliers-guide/ra-consultants-private-limited 2023-10-02T13:59:57-04:00 https://www.raps.org/resources/suppliers-guide/reed-tech 2023-04-04T01:28:33-04:00 https://www.raps.org/resources/suppliers-guide/regdesk 2024-09-24T11:38:00-04:00 https://www.raps.org/resources/suppliers-guide/regxia-inc 2023-10-24T11:29:38-04:00 https://www.raps.org/resources/suppliers-guide/regulis 2024-09-16T10:05:07-04:00 https://www.raps.org/resources/suppliers-guide/resolve-surgical-technologies 2024-12-03T12:25:53-05:00 https://www.raps.org/resources/suppliers-guide/rimsys-llc 2023-04-05T23:32:44-04:00 https://www.raps.org/resources/suppliers-guide/rqm 2023-04-21T14:37:41-04:00 https://www.raps.org/resources/suppliers-guide/rqsolutions-pty-ltd 2023-04-04T01:34:59-04:00 https://www.raps.org/resources/suppliers-guide/rws-life-sciences 2023-04-04T01:35:16-04:00 https://www.raps.org/resources/suppliers-guide/scilucent-inc 2023-04-04T19:18:21-04:00 https://www.raps.org/resources/suppliers-guide/sesen 2025-09-03T13:23:15-04:00 https://www.raps.org/resources/suppliers-guide/schlafender-hase 2023-04-21T14:36:16-04:00 https://www.raps.org/resources/suppliers-guide/strategic-regulatory-solutions-inc 2023-08-17T10:46:34-04:00 https://www.raps.org/resources/suppliers-guide/suppliers-guide-listing-request 2023-03-24T21:53:33-04:00 https://www.raps.org/resources/suppliers-guide/synterex-inc 2025-10-15T17:29:38-04:00 https://www.raps.org/resources/suppliers-guide/telos-partners-llc 2023-04-04T01:42:03-04:00 https://www.raps.org/resources/suppliers-guide/temple-university-regulatory-affairs-and-quality 2023-08-17T11:21:47-04:00 https://www.raps.org/resources/suppliers-guide/trinetx 2025-03-25T13:40:59-04:00 https://www.raps.org/resources/suppliers-guide/trinzo 2025-03-19T09:22:24-04:00 https://www.raps.org/resources/suppliers-guide/ways-pharmaceutical-services 2023-04-04T02:06:53-04:00 https://www.raps.org/resources/suppliers-guide/university-of-georgia-college-of-pharmacy-internat 2023-04-21T14:36:39-04:00 https://www.raps.org/resources/suppliers-guide/university-of-georgia-international-biomedical 2025-06-03T13:51:55-04:00 https://www.raps.org/resources/suppliers-guide/usp 2024-06-26T13:30:14-04:00 https://www.raps.org/resources/suppliers-guide/v-advices-srl 2023-10-02T13:34:12-04:00 https://www.raps.org/resources/suppliers-guide/veristat 2023-05-23T16:15:51-04:00 https://www.raps.org/certifications/rac/rac-value/alyssa-manno 2023-09-01T16:52:01-04:00 https://www.raps.org/certifications/rac/rac-value/andrea-armando 2023-09-01T16:53:39-04:00 https://www.raps.org/certifications/rac/rac-value/andrea-chamblee 2023-09-01T16:54:00-04:00 https://www.raps.org/certifications/rac/rac-value/anjali-atal-gupta 2025-03-19T00:01:18-04:00 https://www.raps.org/certifications/rac/rac-value/darshika-doshi 2024-02-13T10:24:09-05:00 https://www.raps.org/certifications/rac/rac-value/elizabeth-bereza 2023-12-13T06:00:02-05:00 https://www.raps.org/certifications/rac/rac-value/emily-nesbitt 2023-09-01T16:55:00-04:00 https://www.raps.org/certifications/rac/rac-value/grace-powers 2023-09-01T16:55:23-04:00 https://www.raps.org/certifications/rac/rac-value/janmeet-anant 2023-09-01T16:55:56-04:00 https://www.raps.org/certifications/rac/rac-value/jay-vaishnav 2023-09-01T16:56:23-04:00 https://www.raps.org/certifications/rac/rac-value/ji-eun-kim 2023-09-01T16:56:46-04:00 https://www.raps.org/certifications/rac/rac-value/jonali-ramani 2023-11-15T09:44:48-05:00 https://www.raps.org/certifications/rac/rac-value/julie-watchorn 2023-09-01T16:57:07-04:00 https://www.raps.org/certifications/rac/rac-value/khemraj-hirani 2024-02-13T10:05:04-05:00 https://www.raps.org/certifications/rac/rac-value/kristen-meany 2023-09-01T17:20:06-04:00 https://www.raps.org/certifications/rac/rac-value/kristen-ortiz 2023-05-04T18:12:03-04:00 https://www.raps.org/certifications/rac/rac-value/kristin-totushek 2023-09-01T17:20:57-04:00 https://www.raps.org/certifications/rac/rac-value/loganathan-kumarasamy 2023-09-01T17:21:18-04:00 https://www.raps.org/certifications/rac/rac-value/manan-shah 2023-09-01T17:21:39-04:00 https://www.raps.org/certifications/rac/rac-value/marshall-hoke 2023-09-01T17:21:58-04:00 https://www.raps.org/certifications/rac/rac-value/michelle-lott 2023-09-01T17:22:18-04:00 https://www.raps.org/certifications/rac/rac-value/paul-swift 2023-09-01T17:22:41-04:00 https://www.raps.org/certifications/rac/rac-value/rajeev-aneja 2023-09-01T17:23:05-04:00 https://www.raps.org/certifications/rac/rac-value/rania-nosseir 2023-09-01T17:23:28-04:00 https://www.raps.org/certifications/rac/rac-value/ratinder-dhami 2023-09-01T17:23:56-04:00 https://www.raps.org/certifications/rac/rac-value/renata-lavach-savy 2023-09-05T02:00:04-04:00 https://www.raps.org/certifications/rac/rac-value/shalin-parikh 2023-09-18T11:10:11-04:00 https://www.raps.org/certifications/rac/rac-value/shikha-malik 2023-09-01T17:24:58-04:00 https://www.raps.org/certifications/rac/rac-value/tyler-ting 2023-09-01T17:25:20-04:00 https://www.raps.org/certifications/rac/rac-value/tyler-vandivort 2025-07-28T14:11:43-04:00 https://www.raps.org/certifications/rac/rac-value/vidita-desai 2023-10-18T00:01:08-04:00 https://www.raps.org/certifications/rac/rac-value/vijayalakshmi-ramanan 2023-09-01T17:25:49-04:00 https://www.raps.org/certifications/rac/rac-value/zedong-dong 2023-09-01T17:26:09-04:00 https://www.raps.org/news-and-articles/news-articles/2026/3/former-officials-propose-changes-to-fda-s-plausibl Regulatory Focus en 2026-03-31 Former officials propose changes to FDAs plausible mechanism framework https://www.raps.org/news-and-articles/news-articles/2026/3/pharma-industry-raises-concerns-as-eu-consults-on Regulatory Focus en 2026-03-31 Pharma industry raises concerns as EU consults on plan to ban PFAS https://www.raps.org/news-and-articles/news-articles/2026/3/ema-proposes-new-method-to-reduce-animal-drug-test Regulatory Focus en 2026-03-31 EMA proposes new method to reduce animal drug testing https://www.raps.org/news-and-articles/news-articles/2026/3/recon-novo-to-offer-discount-wegovy-subscription-f Regulatory Focus en 2026-03-31 Recon: Novo to offer discount Wegovy subscription for self-pay US consumers Lilly to acquire Centessa in deal worth up to 78B https://www.raps.org/news-and-articles/news-articles/2026/3/ema-details-data-quality-considerations-when-using Regulatory Focus en 2026-03-30 EMA details data quality considerations when using RWD https://www.raps.org/news-and-articles/news-articles/2026/3/recon-insilico,-eli-lilly-strike-$2-75b-ai-drug-de Regulatory Focus en 2026-03-30 Recon: Insilico, Eli Lilly strike 275B AI drug development deal FDA clears Butterfly Networks AI ultrasound pregnancy tool https://www.raps.org/news-and-articles/news-articles/2026/3/nick Regulatory Focus en 2026-03-30 APAC Roundup: Indias CDSCO streamlines requests to export active substances to Europe https://www.raps.org/news-and-articles/news-articles/2026/3/this-week-at-fda-reactions-to-fdas-bayesian-method Regulatory Focus en 2026-03-27 This Week at FDA: Reactions to FDAs Bayesian methods guidance, GDUFA science report, and more https://www.raps.org/news-and-articles/news-articles/2026/3/fda-finalizes-guidance-on-patient-preference-infor Regulatory Focus en 2026-03-27 FDA finalizes guidance on patient preference information for devices https://www.raps.org/news-and-articles/news-articles/2026/3/industry-calls-for-synchronized-implementation-of Regulatory Focus en 2026-03-26 Industry calls for synchronized implementation of ICH M4QR2 https://www.raps.org/news-and-articles/news-articles/2026/3/fda-issues-warning-letters-for-false-advertising-c Regulatory Focus en 2026-03-26 FDA issues warning letters for false advertising, CGMP violations, and more https://www.raps.org/news-and-articles/news-articles/2026/3/recon-fda-approves-denali-s-hunter-syndrome-drug; Regulatory Focus en 2026-03-26 Recon: FDA approves Denalis Hunter syndrome drug Merck to buy Terns for 67B https://www.raps.org/news-and-articles/news-articles/2026/3/advocacy-group-calls-for-greater-transparency-at-f Regulatory Focus en 2026-03-26 Advocacy group calls for greater transparency at FDA https://www.raps.org/news-and-articles/news-articles/2026/3/euro-roundup-ema-finalizes-guideline-on-chemistry Regulatory Focus en 2026-03-26 Euro Roundup: EMA finalizes guideline on chemistry of active substances https://www.raps.org/news-and-articles/news-articles/2026/3/regulatory-affairs-kellogg-business-interview Regulatory Focus en 2026-03-26 The past, present, and future of the regulatory affairs executive https://www.raps.org/news-and-articles/news-articles/2026/3/pdufa-viii-industry-questions-increased-spending-d Regulatory Focus en 2026-03-25 PDUFA VIII: Industry questions increased spending despite staff cuts, agreement on RDEA https://www.raps.org/news-and-articles/news-articles/2026/3/mhra-moves-to-reduce-animal-testing-with-new-guida Regulatory Focus en 2026-03-25 MHRA moves to reduce animal testing with new guidance https://www.raps.org/news-and-articles/news-articles/2026/3/gao-calls-on-fda-to-finalize-guidance-on-adcomm-co Regulatory Focus en 2026-03-24 GAO calls on FDA to finalize guidance on adcomm COI https://www.raps.org/news-and-articles/news-articles/2026/3/ema-issues-guidance-on-gmp-considerations-for-addi Regulatory Focus en 2026-03-24 EMA issues guidance on GMP considerations for additive manufacturing https://www.raps.org/news-and-articles/news-articles/2026/3/gdufa-iv-negotiations-address-dmfs,-internal-consu Regulatory Focus en 2026-03-24 GDUFA IV: Negotiations address DMFs, internal consultations, imminent actions https://www.raps.org/news-and-articles/news-articles/2026/3/recon-gilead-to-acquired-ouro-in-$2b-deal;-major-d Regulatory Focus en 2026-03-24 Recon: Gilead to acquire Ouro in 2B deal Major drugmakers slashed headcount by over 22K in 2025 https://www.raps.org/news-and-articles/news-articles/2026/3/eu-officials-optimistic-about-proposed-mdr-ivdr-re Regulatory Focus en 2026-03-23 EU officials optimistic about proposed MDRIVDR reforms https://www.raps.org/news-and-articles/news-articles/2026/3/asia-pacific-roundup-philippine-fda-seeks-feedback Regulatory Focus en 2026-03-23 Asia-Pacific Roundup: Philippine FDA seeks feedback on standardizing pharma licensing info https://www.raps.org/news-and-articles/news-articles/2026/3/recon-pfizer-plans-to-submit-lyme-vaccine-despite Regulatory Focus en 2026-03-23 Recon: Pfizer plans to submit Lyme vaccine despite primary endpoint miss FDA approves BMS Hodgkins lymphoma drug https://www.raps.org/news-and-articles/news-articles/2026/3/this-week-at-fda-fda-seeks-input-on-cnpv,-new-appr Regulatory Focus en 2026-03-20 This Week at FDA: FDA seeks input on CNPV, new approvals, and more https://www.raps.org/news-and-articles/news-articles/2026/3/study-ai-enabled-pediatric-medical-devices-rare,-l Regulatory Focus en 2026-03-20 Study: AI-enabled pediatric medical devices rare, limited to few clinical areas https://www.raps.org/news-and-articles/news-articles/2026/3/fda-warns-four-firms-in-india-and-germany-for-gmp, Regulatory Focus en 2026-03-19 FDA warns four firms in India and Germany for GMP, BIMO violations https://www.raps.org/news-and-articles/news-articles/2026/3/euro-roundup-ema-launches-new-prime-tools-to-accel Regulatory Focus en 2026-03-19 Euro Roundup: EMA launches new PRIME tools to accelerate treatments for unmet medical needs https://www.raps.org/news-and-articles/news-articles/2026/3/recon-novo-s-wegovy-nabs-fda-approval-for-higher-d Regulatory Focus en 2026-03-19 Recon: Novos Wegovy nabs FDA approval for higher dose under CNPV program FDA authorizes JJs oral psoriasis drug https://www.raps.org/news-and-articles/news-articles/2026/3/fda-drafts-guidance-on-animal-testing-alternatives Regulatory Focus en 2026-03-18 FDA drafts guidance on animal testing alternatives https://www.raps.org/news-and-articles/news-articles/2026/3/industry-asks-fda-to-affirm-bayesian-methods-guida Regulatory Focus en 2026-03-18 Industry asks FDA to affirm Bayesian methods guidance applies broadly to drugs https://www.raps.org/news-and-articles/news-articles/2026/3/fda-finalizes-guidance-on-assessing-bioequivalence Regulatory Focus en 2026-03-17 FDA finalizes guidance on assessing bioequivalence of topical drugs https://www.raps.org/news-and-articles/news-articles/2026/3/mdufa-vi-fda-industry-make-headway-in-reauthorizat Regulatory Focus en 2026-03-17 MDUFA VI: FDA, industry make headway in reauthorization negotiations https://www.raps.org/news-and-articles/news-articles/2026/3/recon-judge-blocks-cdc-s-overhaul-of-childhood-vac Regulatory Focus en 2026-03-17 Recon: Judge blocks CDCs overhaul of childhood vaccines FDA rejects Aldeyras eye disorder drug https://www.raps.org/news-and-articles/news-articles/2026/3/pdufa-viii-negotiations-touch-on-patient-experienc Regulatory Focus en 2026-03-16 PDUFA VIII: Negotiations touch on patient experience data, reserve funding, fee waivers, and more https://www.raps.org/news-and-articles/news-articles/2026/3/experts-propose-new-framework-for-overseeing-genai Regulatory Focus en 2026-03-16 Experts propose new framework for overseeing genAI health tools https://www.raps.org/news-and-articles/news-articles/2026/3/asia-pacific-roundup-india-s-cdsco-posts-draft-leg Regulatory Focus en 2026-03-16 Asia-Pacific Roundup: Indias CDSCO posts draft legislation on manufacturing change approvals, notifications https://www.raps.org/news-and-articles/news-articles/2026/3/recon-gsk-nabs-fda-authorization-for-expanded-rsv Regulatory Focus en 2026-03-16 Recon: GSK nabs FDA authorization for expanded RSV jab indication Mideast war disrupts regions pharma supply chain https://www.raps.org/news-and-articles/news-articles/2026/3/ema-proposes-new-paper-on-proof-of-concept-studies Regulatory Focus en 2026-03-13 EMA proposes new paper on proof-of-concept studies for pediatric oncology drugs https://www.raps.org/news-and-articles/news-articles/2026/3/this-week-at-fda-prasads-second-exit-from-fda-acip Regulatory Focus en 2026-03-13 This Week at FDA: Prasads second exit from FDA, ACIP backs off COVID-19 vaccine, more https://www.raps.org/news-and-articles/news-articles/2026/3/expert-stryker-cyberattack-could-lead-fda-to-reass Regulatory Focus en 2026-03-13 Expert: Stryker cyberattack could lead FDA to reassess cybersecurity requirements https://www.raps.org/news-and-articles/news-articles/2026/3/fda-finalizes-guidance-on-weight-loss-devices Regulatory Focus en 2026-03-12 FDA finalizes guidance on weight-loss devices https://www.raps.org/news-and-articles/news-articles/2026/3/euro-roundup-ema-releases-strategy-for-implementin Regulatory Focus en 2026-03-12 Euro Roundup: EMA releases strategy for implementing ICH guideline on post-approval safety data https://www.raps.org/news-and-articles/news-articles/2026/3/recon-lilly-warns-of-impurities-in-compounded-vers Regulatory Focus en 2026-03-12 Recon: Lilly warns of impurities in compounded versions of its weight-loss drugs Abivax denies rumors of takeover by AstraZeneca https://www.raps.org/news-and-articles/news-articles/2026/3/eu-regulators-update-workplan-for-leveraging-ai-an Regulatory Focus en 2026-03-11 EU regulators update workplan for leveraging AI and big data https://www.raps.org/news-and-articles/news-articles/2026/3/fda-consolidates-adverse-events-reporting-systems Regulatory Focus en 2026-03-11 FDA consolidates adverse events reporting systems https://www.raps.org/news-and-articles/news-articles/2026/3/rcc-regulatory-compliance-certification-autumn-25 Regulatory Focus en 2026-03-11 These professionals passed their RCC exams in autumn 2025 https://www.raps.org/news-and-articles/news-articles/2026/3/novo-nordisk-gets-fda-warning-letter-for-adverse-e Regulatory Focus en 2026-03-10 Novo Nordisk gets FDA warning letter for adverse event reporting violations https://www.raps.org/news-and-articles/news-articles/2026/3/ema-outlines-methods-for-evaluating-supply-chain-v Regulatory Focus en 2026-03-10 EMA outlines methods for evaluating supply chain vulnerabilities https://www.raps.org/news-and-articles/news-articles/2026/3/experts-offer-tips-for-using-ai-for-drug-advertisi Regulatory Focus en 2026-03-10 Experts offer tips for using AI for drug advertising and promotion https://www.raps.org/news-and-articles/news-articles/2026/3/recon-fda-approves-leucovorin-for-treating-ultra-r Regulatory Focus en 2026-03-10 Recon: FDA approves leucovorin for treating ultra-rare genetic disorder BioNTech founders to launch new mRNA startup https://www.raps.org/news-and-articles/news-articles/2026/3/regulatory-writing-career-medical-pharma Regulatory Focus en 2026-03-10 How regulatory writing can help you transition into a regulatory affairs career https://www.raps.org/news-and-articles/news-articles/2026/3/fda-official-details-top-gmp-violations-cited-in-i Regulatory Focus en 2026-03-09 FDA official details top GMP violations cited in inspection reports https://www.raps.org/news-and-articles/news-articles/2026/3/asia-pacific-roundup-india-s-icmr-proposes-single Regulatory Focus en 2026-03-09 Asia-Pacific Roundup: Indias ICMR proposes single ethics committee reviews to streamline multicenter trials https://www.raps.org/news-and-articles/news-articles/2026/3/fda-proposes-major-change-to-biosimilar-pk-study-r Regulatory Focus en 2026-03-09 FDA proposes major change to biosimilar PK study requirements https://www.raps.org/news-and-articles/news-articles/2026/3/recon-prasad-to-leave-fda-after-renewed-controvers Regulatory Focus en 2026-03-09 Recon: Prasad to leave FDA after renewed controversy Novo sheds lawsuits, forges pact with Hims for Wegovy, Ozempic https://www.raps.org/news-and-articles/news-articles/2026/3/this-week-at-fda-fda-official-criticizes-uniqure-s Regulatory Focus en 2026-03-06 This Week at FDA: FDA official criticizes UniQure, states eye cheaper drug imports, and more https://www.raps.org/news-and-articles/news-articles/2026/3/fda-drafts-guidance-on-best-practices-for-respondi Regulatory Focus en 2026-03-06 FDA drafts guidance on best practices for responding to inspection observations https://www.raps.org/news-and-articles/news-articles/2026/3/fda-official-offers-insights-on-agency-s-criteria Regulatory Focus en 2026-03-06 FDA official offers insights on agencys criteria for RWD in regulatory submissions https://www.raps.org/news-and-articles/news-articles/2026/3/journal-of-regulatory-affairs-march-april-2026 Regulatory Focus en 2026-03-06 Journal of Regulatory Affairs: March-April 2026 https://www.raps.org/news-and-articles/news-articles/2026/3/navigating-convergence-and-divergence-between-the Regulatory Focus en 2026-03-06 Navigating convergence and divergence between the EU MDR and EU AI Act https://www.raps.org/news-and-articles/news-articles/2026/3/build-from-the-base-operationalizing-the-eu-ai-act Regulatory Focus en 2026-03-06 Build from the base: Operationalizing the EU AI Act through a decisiontree approach https://www.raps.org/news-and-articles/news-articles/2026/3/engineering-safety-and-effectiveness-a-first-princ Regulatory Focus en 2026-03-06 Engineering safety and effectiveness: A first-principles approach to drug-device combination products https://www.raps.org/news-and-articles/news-articles/2026/3/regulatory-considerations-for-pharmaceutical-excip Regulatory Focus en 2026-03-06 Regulatory considerations for pharmaceutical excipient selection https://www.raps.org/news-and-articles/news-articles/2026/3/fda-cites-novo-nordisk-again-for-misleading-glp1-a Regulatory Focus en 2026-03-05 FDA cites Novo Nordisk again for misleading GLP-1 ad https://www.raps.org/news-and-articles/news-articles/2026/3/fda-seeks-public-feedback-for-in-home-opioid-dispo Regulatory Focus en 2026-03-05 FDA seeks public feedback for in-home opioid disposal units https://www.raps.org/news-and-articles/news-articles/2026/3/euro-roundup-ema-posts-draft-guidance-on-running-c Regulatory Focus en 2026-03-05 Euro Roundup: EMA posts draft guidance on running clinical trials in public health emergencies https://www.raps.org/news-and-articles/news-articles/2026/3/recon-tenaya-forges-$1-13b-pact-with-alnylam;-fda Regulatory Focus en 2026-03-05 Recon: Tenaya forges 113B pact with Alnylam FDA approves JJs blood cancer drug under CNPV program https://www.raps.org/news-and-articles/news-articles/2026/3/fda-drafts-guidance-explaining-3-year-clinical-inv Regulatory Focus en 2026-03-04 FDA drafts guidance explaining 3-year clinical investigation exclusivity for new drugs https://www.raps.org/news-and-articles/news-articles/2026/3/fda-issues-long-awaited-final-ndc-rule Regulatory Focus en 2026-03-04 FDA issues long-awaited final NDC rule https://www.raps.org/news-and-articles/news-articles/2026/3/study-patients-may-not-understand-evidentiary-diff Regulatory Focus en 2026-03-03 Study: Patients may not understand evidentiary differences for conditionally approved drugs https://www.raps.org/news-and-articles/news-articles/2026/3/fda-official-core-inspectional-functions,-prioriti Regulatory Focus en 2026-03-03 FDA official: Core inspectional functions, priorities unchanged despite leadership changes https://www.raps.org/news-and-articles/news-articles/2026/3/experts-recommend-targeted-internal-communication Regulatory Focus en 2026-03-03 Experts recommend targeted internal communication for sharing regulatory intelligence https://www.raps.org/news-and-articles/news-articles/2026/3/recon-hhs-ending-use-of-anthropic-s-claude-ai;-fda Regulatory Focus en 2026-03-03 Recon: HHS ending use of Anthropics Claude AI FDA gives breakthrough designation to AI chatbot for patients undergoing surgery https://www.raps.org/news-and-articles/news-articles/2026/3/ema-proposes-new-microbiome-reflection-paper-amid Regulatory Focus en 2026-03-02 EMA proposes new microbiome reflection paper amid growing interest https://www.raps.org/news-and-articles/news-articles/2026/3/asia-pacific-roundup-compliance-issues-drive-tga-t Regulatory Focus en 2026-03-02 Asia-Pacific Roundup: Compliance issues drive TGA to float changes to charge exemption scheme https://www.raps.org/news-and-articles/news-articles/2026/3/fda-seeks-feedback-on-overhaul-of-its-supac-guidel Regulatory Focus en 2026-03-02 FDA seeks feedback on overhaul of its SUPAC guidelines https://www.raps.org/news-and-articles/news-articles/2026/3/recon-uniqure-pursues-path-forward-for-huntington Regulatory Focus en 2026-03-02 Recon: UniQure pursues path forward for Huntingtons treatment despite FDA block Pfizer CEO critical of FDAs Prasad https://www.raps.org/news-and-articles/news-articles/2026/2/this-week-at-fda-speedy-drug-review-bonuses,-makar Regulatory Focus en 2026-02-27 This Week at FDA: Speedy drug review bonuses, Makary defends Prasad, and more https://www.raps.org/news-and-articles/news-articles/2026/2/medical-device-industry-expresses-concern-on-direc Regulatory Focus en 2026-02-27 Medical device industry expresses concern on direction of FDAs TAP 20 program https://www.raps.org/news-and-articles/news-articles/2026/2/fda-s-handling-of-rare-disease-therapies-criticize Regulatory Focus en 2026-02-26 FDAs handling of rare disease therapies criticized in Senate hearing https://www.raps.org/news-and-articles/news-articles/2026/2/imdrf-publishes-regulatory-reliance-playbook-docum Regulatory Focus en 2026-02-26 IMDRF publishes regulatory reliance playbook, document on selecting adverse event terminologies https://www.raps.org/news-and-articles/news-articles/2026/2/euro-roundup-eu-court-dismisses-industry-s-call-to Regulatory Focus en 2026-02-26 Euro Roundup: EU court dismisses industrys call to annul wastewater treatment directive https://www.raps.org/news-and-articles/news-articles/2026/2/recon-fda-approves-first-line-indication-for-boehr Regulatory Focus en 2026-02-26 Recon: FDA approves first line indication for Boehringers lung cancer drug FDA planning bonuses to staff for speedy drug reviews https://www.raps.org/news-and-articles/news-articles/2026/2/combo-products-drug-industry-groups-seek-more-clar Regulatory Focus en 2026-02-25 Combo products, drug industry groups seek more clarity about cross-center master file guidance https://www.raps.org/news-and-articles/news-articles/2026/2/fda-s-cder-agenda-includes-new-guidance-on-digital Regulatory Focus en 2026-02-25 FDAs CDER agenda includes new guidance on digital health technologies and AI in manufacturing https://www.raps.org/news-and-articles/news-articles/2026/2/fda-cites-companies-for-cgmp-marketing-authorizati Regulatory Focus en 2026-02-24 FDA cites companies for CGMP, marketing authorization, and clinical trial violations https://www.raps.org/news-and-articles/news-articles/2026/2/makary-touts-fda-speed,-flexibility-for-rare-disea Regulatory Focus en 2026-02-24 Makary touts FDA speed, flexibility for rare disease drugs https://www.raps.org/news-and-articles/news-articles/2026/2/recon-novo-nordisk-to-slash-us-list-prices-for-oze Regulatory Focus en 2026-02-24 Recon: Novo Nordisk to slash US list prices for Ozempic, Wegovy BioMarin withdraws gene therapy Roctavian after failing to find buyer https://www.raps.org/news-and-articles/news-articles/2026/2/fda-proposes-plausible-mechanism-pathway-for-ultra Regulatory Focus en 2026-02-23 FDA proposes plausible mechanism pathway for ultra-rare disease therapies https://www.raps.org/news-and-articles/news-articles/2026/2/industry-clamors-for-clearer-guidance-on-transitio Regulatory Focus en 2026-02-23 Industry clamors for clearer guidance on transition to ICH M4QR2 https://www.raps.org/news-and-articles/news-articles/2026/2/recon-gilead-to-purchase-arcellx-for-nearly-$8b;-t Regulatory Focus en 2026-02-23 Recon: Gilead to purchase Arcellx for nearly 8B Top CDC deputy abruptly resigns https://www.raps.org/news-and-articles/news-articles/2026/2/asia-pacific-roundup-new-zealand-s-medsafe-seeks-f Regulatory Focus en 2026-02-23 Asia-Pacific Roundup: New Zealands Medsafe seeks feedback on verification pathway for new medicines https://www.raps.org/news-and-articles/news-articles/2026/2/this-week-at-fda-single-pivotal-trials-fda-reverse Regulatory Focus en 2026-02-20 This Week at FDA: Single pivotal trials, FDA reverses course to review Moderna flu vaccine, and Makarys OTC turn https://www.raps.org/news-and-articles/news-articles/2026/2/senate-help-proposes-reforms-to-fdas-regulatory-fr Regulatory Focus en 2026-02-20 Senate HELP chair proposes reforms to FDAs regulatory framework https://www.raps.org/news-and-articles/news-articles/2026/2/generic-industry-against-giving-fee-breaks-to-firm Regulatory Focus en 2026-02-19 Generic industry against giving fee breaks to firms setting up operations in the US https://www.raps.org/news-and-articles/news-articles/2026/2/euro-roundup-ema-seeks-feedback-on-plans-to-draft Regulatory Focus en 2026-02-19 Euro Roundup: EMA seeks feedback on plans to draft myasthenia gravis clinical trial guideline https://www.raps.org/news-and-articles/news-articles/2026/2/recon-hims-hers-to-buy-australia-s-eucalyptus-for Regulatory Focus en 2026-02-19 Recon: Hims Hers to buy Australias Eucalyptus for up to 115B BioNTech sues Moderna over COVID vaccine patents https://www.raps.org/news-and-articles/news-articles/2026/2/experts-react-to-fda-s-shift-to-single-pivotal-tri Regulatory Focus en 2026-02-18 Experts react to FDAs shift to single pivotal trials for most drugs https://www.raps.org/news-and-articles/news-articles/2026/2/pharma-groups-pressure-fda-to-finalize-ndc-rule Regulatory Focus en 2026-02-18 Pharma groups pressure FDA to finalize NDC rule https://www.raps.org/news-and-articles/news-articles/2026/2/experts-argue-recent-fda-expert-panels-may-violate Regulatory Focus en 2026-02-17 Experts argue recent FDA expert panels may violate FACA requirements https://www.raps.org/news-and-articles/news-articles/2026/2/uk-mhra-proposes-indefinite-acceptance-of-ce-marke Regulatory Focus en 2026-02-17 MHRA proposes indefinite acceptance of CE-marked medical devices https://www.raps.org/news-and-articles/news-articles/2026/2/fda-warns-contract-manufacturer-for-gmp-violations Regulatory Focus en 2026-02-17 FDA warns contract manufacturer for GMP violations, clinical investigator for not following trial protocol https://www.raps.org/news-and-articles/news-articles/2026/2/recon-danaher-to-purchase-masimo-for-$9-9b-eu-auth Regulatory Focus en 2026-02-17 Recon: Danaher to purchase Masimo for 99B EU authorizes higher dose of Novos Wegovy https://www.raps.org/news-and-articles/news-articles/2026/2/eu-pharmaceutical-groups-suggest-fixes-to-ich-e20 Regulatory Focus en 2026-02-16 EU pharmaceutical groups suggest fixes to ICH E20 guideline https://www.raps.org/news-and-articles/news-articles/2026/2/fda-cites-janssen-sobi-for-overstating-benefits-un Regulatory Focus en 2026-02-16 FDA cites Janssen, Sobi for overstating benefits, understating risks in DTC TV ads https://www.raps.org/news-and-articles/news-articles/2026/2/asia-pacific-roundup-pmda-smooths-overseas-biotech Regulatory Focus en 2026-02-16 Asia-Pacific Roundup: PMDA smooths overseas biotechs path to Japan with one-stop service platform https://www.raps.org/news-and-articles/news-articles/2026/2/recon-lilly-stockpiles-$1-5b-of-weight-loss-pill-i Regulatory Focus en 2026-02-16 Recon: Lilly stockpiles 15B of weight loss pill in advance of FDA approval FDA rejects Disc Medicines porphyria drug https://www.raps.org/news-and-articles/news-articles/2026/2/this-week-at-fda-moderna-flu-vaccine-refused-forme Regulatory Focus en 2026-02-13 This Week at FDA: Moderna flu vaccine refused, former FDA official joins lobby group, and more https://www.raps.org/news-and-articles/news-articles/2026/2/fda-cites-firms-for-cgmp-and-testing-violations Regulatory Focus en 2026-02-13 FDA cites firms for CGMP and testing violations https://www.raps.org/news-and-articles/news-articles/2026/2/ema-said-stepwise-pip-pilot-is-feasible-in-expedit Regulatory Focus en 2026-02-13 EMA said stepwise PIP pilot is feasible in expediting pediatric drug development https://www.raps.org/news-and-articles/news-articles/2026/2/fda-approves-labeling-changes-for-six-menopausal-h Regulatory Focus en 2026-02-12 FDA approves labeling changes for six menopausal hormone therapy products https://www.raps.org/news-and-articles/news-articles/2026/2/euro-roundup-ema-finalizes-guideline-on-monitoring Regulatory Focus en 2026-02-12 Euro Roundup: EMA finalizes guideline on monitoring drug safety in pregnant and breastfeeding women https://www.raps.org/news-and-articles/news-articles/2026/2/recon-prasad-went-against-fda-staff-to-refuse-to-r Regulatory Focus en 2026-02-12 Recon: Prasad went against FDA staff to refuse to review Modernas flu vaccine Sanofi ousts Paul Hudson as CEO https://www.raps.org/news-and-articles/news-articles/2026/2/stakeholders-ask-fda-for-more-clarity-predictabili Regulatory Focus en 2026-02-11 Stakeholders ask FDA for more clarity, predictability for nonprescription drugs https://www.raps.org/news-and-articles/news-articles/2026/2/mdufa-vi-industry-seeks-changes-to-de-novo,-pre-su Regulatory Focus en 2026-02-11 MDUFA VI: Industry seeks changes to de novo, pre-submission programs https://www.raps.org/news-and-articles/news-articles/2026/2/study-price,-therapeutic-value-impact-internationa Regulatory Focus en 2026-02-11 Study: Price, therapeutic value impact international submission times for new drugs https://www.raps.org/news-and-articles/news-articles/2026/2/ich-adopts-m15-guideline-on-model-informed-drug-de Regulatory Focus en 2026-02-10 ICH adopts M15 guideline on model-informed drug development https://www.raps.org/news-and-articles/news-articles/2026/2/fda-cites-novo-nordisk-for-airing-misleading-wegov Regulatory Focus en 2026-02-10 FDA cites Novo Nordisk for airing misleading Wegovy ad https://www.raps.org/news-and-articles/news-articles/2026/2/recon-fda-denies-regenxbio-s-gene-therapy-for-hunt Regulatory Focus en 2026-02-10 Recon: FDA denies Regenxbios gene therapy for Hunter syndrome Moderna signs deal to manufacture mRNA vaccines in Mexico https://www.raps.org/news-and-articles/news-articles/2026/2/ema-proposes-gmp-update-to-eudralex-to-address-nit Regulatory Focus en 2026-02-09 EMA proposes GMP update to EudraLex to address nitrosamine impurities https://www.raps.org/news-and-articles/news-articles/2026/2/stakeholders-ask-fda-to-expand-guidance-on-streaml Regulatory Focus en 2026-02-09 Stakeholders ask FDA to expand guidance on streamlining testing of single-target monoclonal antibodies https://www.raps.org/news-and-articles/news-articles/2026/2/asia-pacific-roundup-cdsco-seeks-feedback-on-apply Regulatory Focus en 2026-02-09 Asia-Pacific Roundup: CDSCO seeks feedback on applying to import in vitro diagnostics into India https://www.raps.org/news-and-articles/news-articles/2026/2/recon-eli-lilly-to-buy-biotech-orna-for-up-to-$2-4 Regulatory Focus en 2026-02-09 Recon: Eli Lilly to buy biotech Orna for up to 24B Novo sues Hims to stop obesity drug copycats https://www.raps.org/news-and-articles/news-articles/2026/2/pduva-viii-industry-seeks-automatic-post-inspectio Regulatory Focus en 2026-02-06 PDUVA VIII: Industry seeks automatic post-inspection meetings after receiving a 483 https://www.raps.org/news-and-articles/news-articles/2026/2/this-week-at-fda-qmsr-and-precheck-kickoff-makary Regulatory Focus en 2026-02-06 This Week at FDA: QMSR and PreCheck kickoff, Makary tries to ease CNPV concerns, and more https://www.raps.org/news-and-articles/news-articles/2026/2/pharma-expert-discusses-effort-to-standardize-cmc Regulatory Focus en 2026-02-06 Pharma expert discusses effort to standardize CMC quality information https://www.raps.org/news-and-articles/news-articles/2026/2/fda-warns-drug-device-makers-for-cgmp-violations Regulatory Focus en 2026-02-05 FDA warns drug, device makers for CGMP violations https://www.raps.org/news-and-articles/news-articles/2026/2/fda-proposes-waiving-gdufa-facility-fees-for-domes Regulatory Focus en 2026-02-05 FDA proposes waiving GDUFA facility fees for domestic manufacturers https://www.raps.org/news-and-articles/news-articles/2026/2/euro-roundup-ema-seeks-feedback-on-the-use-of-baye Regulatory Focus en 2026-02-05 Euro Roundup: EMA seeks feedback on the use of Bayesian methods in clinical development https://www.raps.org/news-and-articles/news-articles/2026/2/recon-hims-markets-cheaper-glp-1-weight-loss-thera Regulatory Focus en 2026-02-05 Recon: Hims markets cheaper GLP-1 weight loss therapy in US TrumpRx website to launch Thursday https://www.raps.org/news-and-articles/news-articles/2026/2/fda-reissues-cybersecurity-guidance-to-align-with Regulatory Focus en 2026-02-04 FDA reissues cybersecurity guidance to align with QMSR https://www.raps.org/news-and-articles/news-articles/2026/2/fda,-ema-officials-encourage-companies-to-pilot-ec Regulatory Focus en 2026-02-03 FDA, EMA officials encourage companies to pilot eCTD 40 https://www.raps.org/news-and-articles/news-articles/2026/2/eu-commission-mdrivdr-includes-changes-to-medical Regulatory Focus en 2026-02-03 EU Commission MDRIVDR includes changes to medical device software classification, AI Act delay https://www.raps.org/news-and-articles/news-articles/2026/2/recon-fda-rejects-astrazeneca-s-lupus-therapy-saph Regulatory Focus en 2026-02-03 Recon: FDA rejects AstraZenecas lupus therapy Saphnelo MAHA movement turns to dismantle state vaccine laws https://www.raps.org/news-and-articles/news-articles/2026/2/qmsr-is-live-expert-says-new-rule-may-be-challengi Regulatory Focus en 2026-02-02 QMSR is Live: Expert says new rule may be challenging for smaller firms, combination product makers https://www.raps.org/news-and-articles/news-articles/2026/2/fda-announces-formal-launch-of-precheck-program Regulatory Focus en 2026-02-02 FDA announces formal launch of PreCheck program https://www.raps.org/news-and-articles/news-articles/2026/2/asia-pacific-roundup-china-overhauls-drug-administ Regulatory Focus en 2026-02-02 Asia-Pacific Roundup: China overhauls drug administration law with a focus on incentivizing innovation https://www.raps.org/news-and-articles/news-articles/2026/2/recon-fda-rejects-aquestive-s-allergy-therapy-over Regulatory Focus en 2026-02-02 Recon: FDA rejects Aquestives allergy therapy over packaging concerns Novos CagriSema tops Wegovy in Phase 3 diabetes study https://www.raps.org/news-and-articles/news-articles/2026/1/this-week-at-fda-cdrh-annual-report,-partial-shutd Regulatory Focus en 2026-01-30 This Week at FDA: CDRH annual report, partial shutdown update, and more https://www.raps.org/news-and-articles/news-articles/2026/1/ema-issues-guidelines-on-quality,-therapeutic-equi Regulatory Focus en 2026-01-29 EMA issues guidelines on quality, therapeutic equivalence of inhaled drugs https://www.raps.org/news-and-articles/news-articles/2025/1/euro-roundup-ema-seeks-feedback-on-assessing-the-c Regulatory Focus en 2026-01-29 Euro Roundup: EMA seeks feedback on assessing the cardiovascular safety of cancer drugs https://www.raps.org/news-and-articles/news-articles/2025/1/recon-astrazeneca-announces-$15b-china-investment Regulatory Focus en 2026-01-29 Recon: AstraZeneca announces 15B China investment UK says severe pancreatitis and death linked to GLP-1 drugs https://www.raps.org/news-and-articles/news-articles/2026/1/makary-s-priorities-faster-reviews,-domestic-manuf Regulatory Focus en 2026-01-28 Makarys priorities: Faster reviews, domestic manufacturing, and AI https://www.raps.org/news-and-articles/news-articles/2026/1/combined-studies-commission-officials-outline-prop Regulatory Focus en 2026-01-28 Combined studies: Commission officials outline proposed reforms https://www.raps.org/news-and-articles/news-articles/2026/1/combination-products-in-the-eu-recap Regulatory Focus en 2026-01-28 100 Global Regulators, Health Authorities, Notified Bodies and Industry Partners Gather in Brussels for 2026 Combination Products in the EU https://www.raps.org/news-and-articles/news-articles/2026/1/eu-officials-detail-proposed-mdr,-ivdr-revisions Regulatory Focus en 2026-01-27 EU officials detail proposed MDR, IVDR revisions https://www.raps.org/news-and-articles/news-articles/2026/1/fda-official-offers-tips-on-leveraging-ai-in-drug Regulatory Focus en 2026-01-27 FDA official offers tips on leveraging AI in drug manufacturing https://www.raps.org/news-and-articles/news-articles/2026/1/recon-china-suspends-sale-of-sun-dementia-drug-in Regulatory Focus en 2026-01-27 Recon: China suspends sale of Sun dementia drug Intellia cleared to resume gene therapy trial after FDA hold https://www.raps.org/news-and-articles/news-articles/2026/1/industry-wants-more-streamlining-following-recent Regulatory Focus en 2026-01-27 Industry wants more streamlining following recent EU reforms https://www.raps.org/news-and-articles/news-articles/2026/1/regulatory-affairs-profession-changes Regulatory Focus en 2026-01-27 11 big ways regulatory affairs has changed in the last 50 years https://www.raps.org/news-and-articles/news-articles/2026/1/industry-spars-over-fda-plan-to-cut-comparative-ef Regulatory Focus en 2026-01-26 Industry spars over FDA plan to cut comparative efficacy studies for biosimilars https://www.raps.org/news-and-articles/news-articles/2026/1/asia-pacific-roundup-india-s-cdsco-halves-clinical Regulatory Focus en 2026-01-26 Asia-Pacific Roundup: Indias CDSCO halves clinical trial review timelines https://www.raps.org/news-and-articles/news-articles/2026/1/recon-drugmakers-pivot-to-ai-to-speed-trials-subm Regulatory Focus en 2026-01-26 Recon: Drugmakers pivot to AI to speed trials, submissions MHRA impounded 20M illegal drugs last year https://www.raps.org/news-and-articles/news-articles/2026/1/these-professionals-earned-their-rac-credentials-i Regulatory Focus en 2026-01-26 These professionals earned their RAC credentials in autumn 2025 https://www.raps.org/news-and-articles/news-articles/2026/1/this-week-at-fda-hhs-ends-aborted-fetal-tissue-res Regulatory Focus en 2026-01-23 This Week at FDA: HHS ends aborted fetal tissue research, PreCheck pilot update, and more https://www.raps.org/news-and-articles/news-articles/2026/1/expert-companies-should-embrace-‘sustainable-compl Regulatory Focus en 2026-01-22 Expert: Companies should embrace sustainable compliance to avoid 483s, warning letters https://www.raps.org/news-and-articles/news-articles/2026/1/fda-drafts-guidance-on-cuffless-blood-pressure-mea Regulatory Focus en 2026-01-22 FDA drafts guidance on cuffless blood pressure measuring devices https://www.raps.org/news-and-articles/news-articles/2026/1/euro-roundup-european-parliament-passes-critical-m Regulatory Focus en 2026-01-22 Euro Roundup: European Parliament passes Critical Medicines Act to strengthen drug supply https://www.raps.org/news-and-articles/news-articles/2026/1/recon-us-to-complete-its-exit-from-who-janux-bms Regulatory Focus en 2026-01-22 Recon: US to complete its exit from WHO Janux, BMS enter 850M deal to develop solid tumor therapy https://www.raps.org/news-and-articles/news-articles/2026/1/fda-warns-hiv-test-distributors-supplement-firm-an Regulatory Focus en 2026-01-22 FDA warns HIV test distributors, supplement firm, and OTC drugmaker https://www.raps.org/news-and-articles/news-articles/2026/1/cber-updates-two-guides-for-staff-on-reviewing-ind Regulatory Focus en 2026-01-20 CBER updates two guides for staff on reviewing INDs and handling clinical holds https://www.raps.org/news-and-articles/news-articles/2026/1/fda-proposes-guidance-on-endpoints-for-multiple-my Regulatory Focus en 2026-01-20 FDA proposes guidance on endpoints for multiple myeloma therapeutics accelerated approval trials https://www.raps.org/news-and-articles/news-articles/2026/1/recon-gsk-to-purchase-rapt-therapeutics,-food-alle Regulatory Focus en 2026-01-20 Recon: GSK to purchase RAPT Therapeutics, food allergy drugmaker, for 22 billion Corvus therapy demonstrates positive results in early-stage eczema study https://www.raps.org/news-and-articles/news-articles/2026/1/eu-commissioned-study-finds-mdr-ivdr-have-dampene Regulatory Focus en 2026-01-19 EU-commissioned study finds MDR, IVDR have dampened medical device investment https://www.raps.org/news-and-articles/news-articles/2026/1/swissmedic-reaches-deal-to-make-significant-staffi Regulatory Focus en 2026-01-19 Swissmedic reaches deal to make significant staffing cuts https://www.raps.org/news-and-articles/news-articles/2026/1/recon-supreme-court-takes-up-‘skinny-labeling-case Regulatory Focus en 2026-01-19 Recon: Supreme Court takes up skinny labeling case EC proposal would double EU regulators medtech staffs https://www.raps.org/news-and-articles/news-articles/2026/1/asia-pacific-roundup-new-zealand-s-medsafe-seeks-f Regulatory Focus en 2026-01-19 Asia-Pacific Roundup: New Zealands Medsafe seeks feedback on planned changes to abbreviated filings https://www.raps.org/news-and-articles/news-articles/2026/1/this-week-at-fda-drug-voucher-program-hits-a-snag Regulatory Focus en 2026-01-16 This Week at FDA: Drug voucher program hits a snag, GOP targets abortion drug, and more https://www.raps.org/news-and-articles/news-articles/2026/1/ema-updates-guideline-on-peripheral-arterial-occlu Regulatory Focus en 2026-01-16 EMA updates guideline on peripheral arterial occlusive disease drugs https://www.raps.org/news-and-articles/news-articles/2026/1/ema-recommended-38-new-drugs-in-2025-fewer-than-pr Regulatory Focus en 2026-01-16 EMA recommended 38 new drugs in 2025, fewer than prior year https://www.raps.org/news-and-articles/news-articles/2026/1/fda-reports-lack-of-interest,-high-rejection-rate Regulatory Focus en 2026-01-15 FDA reports lack of interest, high rejection rate for its STAR program https://www.raps.org/news-and-articles/news-articles/2026/1/recon-boston-scientific-to-purchase-penumbra-for-$ Regulatory Focus en 2026-01-15 Recon: Boston Scientific to purchase Penumbra for 145B FDA delays reviews of two drugs in Commissioners voucher program https://www.raps.org/news-and-articles/news-articles/2026/1/euro-roundup-mhra-shares-clinical-trial-guidance-a Regulatory Focus en 2026-01-15 Euro Roundup: MHRA shares clinical trial guidance ahead of April switch to new UK legislation https://www.raps.org/news-and-articles/news-articles/2026/1/ema-fda-issue-joint-ai-guiding-principles-for-drug Regulatory Focus en 2026-01-14 EMA, FDA issue joint AI guiding principles for drug developers https://www.raps.org/news-and-articles/news-articles/2026/1/fda-continues-ad-enforcement-push-with-first-two-u Regulatory Focus en 2026-01-14 FDA continues ad enforcement push with first two untitled letters 2026 https://www.raps.org/news-and-articles/news-articles/2026/1/cder-approved-46-novel-drugs-in-2025,-half-for-rar Regulatory Focus en 2026-01-13 CDER approved 46 novel drugs in 2025, half for rare diseases https://www.raps.org/news-and-articles/news-articles/2026/1/fda-issues-warning-letters-for-gmp-gcp-violations Regulatory Focus en 2026-01-13 FDA issues warning letters for GMP, GCP violations https://www.raps.org/news-and-articles/news-articles/2026/1/recon-abbvie-strikes-pricing-pact-with-the-white-h Regulatory Focus en 2026-01-13 Recon: AbbVie strikes pricing pact with the White House FDA seeks removal of suicide warnings from weight-loss drugs https://www.raps.org/news-and-articles/news-articles/2026/1/cber-outlines-its-guidance-priorities-for-2026 Regulatory Focus en 2026-01-12 CBER outlines its guidance priorities for 2026 https://www.raps.org/news-and-articles/news-articles/2026/1/fda-touts-new-flexible-approach-to-reviewing-cell Regulatory Focus en 2026-01-12 FDA touts new flexible approach to reviewing cell and gene therapies https://www.raps.org/news-and-articles/news-articles/2026/1/experts-raise-concerns-over-lower-evidentiary-stan Regulatory Focus en 2026-01-12 Experts raise concerns over lower evidentiary standard for FDAs leucovorin approval https://www.raps.org/news-and-articles/news-articles/2026/1/asia-pacific-roundup-china-s-nmpa-updates-regulat Regulatory Focus en 2026-01-12 Asia-Pacific Roundup: Chinas NMPA updates regulations to encourage drug research, innovation https://www.raps.org/news-and-articles/news-articles/2026/1/recon-nvidia-lilly-partner-on-1b-joint-research Regulatory Focus en 2026-01-12 Recon: Nvidia, Lilly partner on 1B joint research AI lab FDA rejects Ataras blood cancer treatment https://www.raps.org/news-and-articles/news-articles/2026/1/introducing-the-journal-of-regulatory-affairs Regulatory Focus en 2026-01-12 Introducing the Journal of Regulatory Affairs https://www.raps.org/news-and-articles/news-articles/2026/1/journal-of-regulatory-affairs,-january-2026-volume Regulatory Focus en 2026-01-12 Journal of Regulatory Affairs, January-February 2026 https://www.raps.org/news-and-articles/news-articles/2026/1/understanding-predetermined-change-control-plans-l Regulatory Focus en 2026-01-12 Understanding predetermined change control plans: Lessons for postmarket innovation and global alignment https://www.raps.org/news-and-articles/news-articles/2026/1/navigating-regulatory-requirements-for-procedure-p Regulatory Focus en 2026-01-12 Navigating regulatory requirements for procedure packs and kits: An overview of US and EU frameworks https://www.raps.org/news-and-articles/news-articles/2026/1/transforming-medication-access-a-novel-regulatory Regulatory Focus en 2026-01-12 Transforming medication access: A novel regulatory pathway for increasing direct-to-consumer access https://www.raps.org/news-and-articles/news-articles/2026/1/cmc-for-cellular-and-gene-therapies-a-comparison-o Regulatory Focus en 2026-01-12 CMC for cellular and gene therapies: A comparison of EU and US regulations https://www.raps.org/news-and-articles/news-articles/2026/1/the-2025-chinese-pharmacopoeia-–-toward-global-har Regulatory Focus en 2026-01-12 The 2025 Chinese Pharmacopoeia Toward global harmonization https://www.raps.org/news-and-articles/news-articles/2026/1/ema-centralized-marketing-authorizations-in-spain Regulatory Focus en 2026-01-12 EMA centralized marketing authorizations in Spain https://www.raps.org/news-and-articles/news-articles/2026/1/enhancing-representation-in-clinical-trials-from-p Regulatory Focus en 2026-01-12 Enhancing representation in clinical trials: From principle to practice https://www.raps.org/news-and-articles/news-articles/2026/1/this-week-at-fda-fda-eases-digital-health-oversigh Regulatory Focus en 2026-01-09 This Week at FDA: FDA eases digital health oversight, MDUFA negotiation update, and more https://www.raps.org/news-and-articles/news-articles/2026/1/fda-issues-guidance-on-use-of-bayesian-methods-to Regulatory Focus en 2026-01-09 FDA issues guidance on use of Bayesian methods to support drug development https://www.raps.org/news-and-articles/news-articles/2026/1/mdcg-outlines-postmarket-surveillance-expectations Regulatory Focus en 2026-01-08 MDCG outlines postmarket surveillance expectations under MDRIVDR https://www.raps.org/news-and-articles/news-articles/2026/1/fda-revises-guidance-on-studying-sex-differences Regulatory Focus en 2026-01-08 FDA revises guidance on studying sex differences, removing gender references https://www.raps.org/news-and-articles/news-articles/2026/1/euro-roundup-notified-bodies-push-to-extend-transi Regulatory Focus en 2026-01-08 Euro Roundup: Notified bodies push to extend transition timelines for MDR and IVDR revisions https://www.raps.org/news-and-articles/news-articles/2026/1/recon-hhs-loses-court-case-affecting-340b-rebate-p Regulatory Focus en 2026-01-08 Recon: HHS loses court case affecting 340B rebate pilot program Eli Lilly to acquire Ventyx for nearly 12B https://www.raps.org/news-and-articles/news-articles/2026/1/industry-groups-urge-fda-to-use-existing-controls Regulatory Focus en 2026-01-07 Industry groups urge FDA to use existing controls to monitor AI-assisted devices https://www.raps.org/news-and-articles/news-articles/2026/1/fda-relaxes-oversight-of-general-wellness-devices Regulatory Focus en 2026-01-07 FDA relaxes oversight of general wellness devices, CDS software https://www.raps.org/news-and-articles/news-articles/2026/1/imdrf-emphasizes-engagement,-governance-reform-in Regulatory Focus en 2026-01-06 IMDRF emphasizes engagement, governance reform in new strategic plan https://www.raps.org/news-and-articles/news-articles/2026/1/stakeholders-weigh-in-on-bsufa-iv-enhancements Regulatory Focus en 2026-01-06 Stakeholders weigh in on BsUFA IV enhancements https://www.raps.org/news-and-articles/news-articles/2026/1/recon-amgen-to-acquire-dark-blue-for-$480m-cdc-sl Regulatory Focus en 2026-01-06 Recon: Amgen to acquire Dark Blue for 480M CDC slashes recommendations for childhood vaccines https://www.raps.org/news-and-articles/news-articles/2026/1/pharma-groups-suggest-modification-to-fda-s-cgt-po Regulatory Focus en 2026-01-05 Pharma groups suggest modification to FDAs CGT postapproval guidance https://www.raps.org/news-and-articles/news-articles/2026/1/fda-clarifies-process-for-disputing-otc-orders-in Regulatory Focus en 2026-01-05 FDA clarifies process for disputing OTC orders in final guidance https://www.raps.org/news-and-articles/news-articles/2026/1/asia-pacific-roundup-india-proposes-banning-over-t Regulatory Focus en 2026-01-05 Asia-Pacific Roundup: India proposes banning over-the-counter syrup sales after contamination crisis https://www.raps.org/news-and-articles/news-articles/2026/1/recon-novo-nordisk-launches-wegovy-pill-in-us-san Regulatory Focus en 2026-01-05 Recon: Novo Nordisk launches Wegovy pill in US Sanofi claims FDA will review diabetes drug age range https://www.raps.org/news-and-articles/news-articles/2025/12/recon-fda-approves-cytokinetics-heart-drug-in-firs Regulatory Focus en 2025-12-22 Recon: FDA approves Cytokinetics heart drug in first for drugmaker Shionogi forges 25 billion buyout of Tanabe Pharmas ALS therapy Radicava https://www.raps.org/news-and-articles/news-articles/2025/12/asia-pacific-roundup-australia-s-tga-seeks-fee-(1) Regulatory Focus en 2025-12-22 Asia-Pacific Roundup: Australias TGA seeks feedback on planned changes to medicine labels https://www.raps.org/news-and-articles/news-articles/2025/12/fda-posts-warning-letters-to-manufacturers-of-brea Regulatory Focus en 2025-12-19 FDA posts warning letters to manufacturers of breast binders https://www.raps.org/news-and-articles/news-articles/2025/12/this-week-fda-staff-raise-alarm-over-cnvp-no-covid Regulatory Focus en 2025-12-19 This Week: FDA staff raise alarm over CNVP, no COVID-19 vaccine boxed warning, and more https://www.raps.org/news-and-articles/news-articles/2025/12/fda-loosens-restrictions-on-using-patient-level-rw Regulatory Focus en 2025-12-18 FDA loosens restrictions on using patient-level RWD in medical device submissions https://www.raps.org/news-and-articles/news-articles/2025/12/recon-eli-lilly-s-obesity-pill-assisted-in-weight Regulatory Focus en 2025-12-18 Recon: Eli Lillys obesity pill assisted in weight loss maintenance after injection switch Takedas AI-generated psoriasis therapy sees Phase 3 success https://www.raps.org/news-and-articles/news-articles/2025/12/eu-commission-proposes-major-reforms-to-mdr Regulatory Focus en 2025-12-18 EU Commission proposes major reforms to MDR https://www.raps.org/news-and-articles/news-articles/2025/12/euro-roundup-eu-parliament-s-public-health-committ Regulatory Focus en 2025-12-18 Euro Roundup: EU Parliaments public health committee adopts a view on critical medicines https://www.raps.org/news-and-articles/news-articles/2025/12/raps-year-in-review-2025 Regulatory Focus en 2025-12-18 RAPS 2025 Year in Review: what we accomplished, together https://www.raps.org/news-and-articles/news-articles/2025/12/fda-finalizes-safety-reporting-guidances-for-spons Regulatory Focus en 2025-12-18 FDA finalizes safety reporting guidances for sponsors and investigators https://www.raps.org/news-and-articles/news-articles/2025/12/mdcg-provides-guidance-on-qualifying-breakthrough Regulatory Focus en 2025-12-16 MDCG provides guidance on qualifying breakthrough devices https://www.raps.org/news-and-articles/news-articles/2025/12/eu-commission-proposes-new-timelines-for-notified Regulatory Focus en 2025-12-16 EU Commission proposes new timelines for notified bodies https://www.raps.org/news-and-articles/news-articles/2025/12/recon-digital-health,-device-leaders-leave-fda;-wa Regulatory Focus en 2025-12-16 Recon: Digital health, device leaders leave FDA Walmart, Target get warning letters for recalled infant formula https://www.raps.org/news-and-articles/news-articles/2025/12/fda-proactively-reached-out-to-janssen-to-offer-a Regulatory Focus en 2025-12-15 FDA proactively reached out to Janssen to offer a CNPV voucher for Tec-Dara https://www.raps.org/news-and-articles/news-articles/2025/12/rf-quarterly,-december-2025-raps-convergence Regulatory Focus en 2025-12-15 RF Quarterly, December 2025: RAPS Convergence https://www.raps.org/news-and-articles/news-articles/2025/12/navigating-global-regulatory-pathways-for-orphan-m Regulatory Focus en 2025-12-15 Navigating global regulatory pathways for orphan medical devices https://www.raps.org/news-and-articles/news-articles/2025/12/companion-diagnostics-best-practices-for-effective Regulatory Focus en 2025-12-15 Companion diagnostics: Best practices for effective collaboration https://www.raps.org/news-and-articles/news-articles/2025/12/implementing-e-labeling-in-pharma-and-medical-devi Regulatory Focus en 2025-12-15 Implementing e-labeling in drugs and medical devices https://www.raps.org/news-and-articles/news-articles/2025/12/can-generative-ai-help-regulatory-teams-scale-up-o Regulatory Focus en 2025-12-15 Can generative AI help regulatory teams scale up operations Pitfalls and best practices https://www.raps.org/news-and-articles/news-articles/2025/12/potential-to-performance-how-regulatory-organizati Regulatory Focus en 2025-12-15 Potential to performance: How regulatory organizations are adopting AI https://www.raps.org/news-and-articles/news-articles/2025/12/ich-looks-to-revamp-its-guidelines-on-cell-and-gen Regulatory Focus en 2025-12-15 ICH looks to revamp its guidelines on cell and gene therapies https://www.raps.org/news-and-articles/news-articles/2025/12/asia-pacific-roundup-new-zealand-s-medsafe-finaliz Regulatory Focus en 2025-12-15 Asia-Pacific Roundup: New Zealands Medsafe finalizes bioequivalence guidelines https://www.raps.org/news-and-articles/news-articles/2025/12/recon-sanofi-inks-1-7b-deal-with-dren-bio-for-aut Regulatory Focus en 2025-12-15 Recon: Sanofi inks 17B deal with Dren Bio for autoimmune therapy MHRA approves GSKs twice-yearly asthma treatment https://www.raps.org/news-and-articles/news-articles/2025/12/this-week-at-fda-anti-abortion-groups-want-makary Regulatory Focus en 2025-12-12 This Week at FDA: Anti-abortion groups want Makary fired, FDA investigating COVID-19 and RSV vaccines https://www.raps.org/news-and-articles/news-articles/2025/12/fda-panel-calls-for-easing-restrictions-on-testost Regulatory Focus en 2025-12-12 FDA panel calls for easing restrictions on testosterone replacement therapy for men https://www.raps.org/news-and-articles/news-articles/2025/12/eu-legislators-reach-agreement-on-landmark-pharmac Regulatory Focus en 2025-12-11 EU legislators reach agreement on landmark pharmaceutical package https://www.raps.org/news-and-articles/news-articles/2025/12/recon-eli-lilly-s-experimental-obesity-drug-slashe Regulatory Focus en 2025-12-11 Recon: Eli Lillys experimental obesity drug slashes weight in study FDA approves first at-home device for depression https://www.raps.org/news-and-articles/news-articles/2025/12/euro-roundup-ema-seeks-feedback-on-plans-to-update Regulatory Focus en 2025-12-11 Euro Roundup: EMA seeks feedback on plans to update good pharmacogenomic practice guideline https://www.raps.org/news-and-articles/news-articles/2025/12/cber-official-stresses-importance-of-preapproval-i Regulatory Focus en 2025-12-10 CBER official stresses importance of preapproval inspection readiness https://www.raps.org/news-and-articles/news-articles/2025/12/fda-issues-warning-letters-for-cgmp-violations-una Regulatory Focus en 2025-12-10 FDA issues warning letters for CGMP violations, unauthorized marketing https://www.raps.org/news-and-articles/news-articles/2025/12/fda-to-tighten-approval-requirements-for-car-t-cel Regulatory Focus en 2025-12-09 FDA to tighten approval requirements for CAR T-cell therapies https://www.raps.org/news-and-articles/news-articles/2025/12/fda-finalizes-guidance-on-promotional-labeling-and Regulatory Focus en 2025-12-09 FDA finalizes guidance on biologic, biosimilar promotional labeling https://www.raps.org/news-and-articles/news-articles/2025/12/recon-fda-investigating-safety-of-infant-rsv-thera Regulatory Focus en 2025-12-09 Recon: FDA investigating safety of infant RSV therapies Lilly to build 6B Alabama plant https://www.raps.org/news-and-articles/news-articles/2025/12/experts-call-on-fda-to-provide-greater-clarity-on Regulatory Focus en 2025-12-08 Experts call on FDA to provide greater clarity on its approach to AI https://www.raps.org/news-and-articles/news-articles/2025/12/commentors-ask-fda-to-withdraw-510(k)-and-thermal Regulatory Focus en 2025-12-08 Commentors ask FDA to withdraw 510k and thermal effects guidances https://www.raps.org/news-and-articles/news-articles/2025/12/asia-pacific-roundup-nmpa-adopts-policy-to-cut-tim Regulatory Focus en 2025-12-08 Asia-Pacific Roundup: NMPA adopts policy to cut time between drug approval and market supply in China https://www.raps.org/news-and-articles/news-articles/2025/12/recon-fda-misses-pdufa-goal-date-for-agios-thalass Regulatory Focus en 2025-12-08 Recon: FDA misses PDUFA goal date for Agios thalassemia therapy Mirum to buy Bluejay for up to 820M https://www.raps.org/news-and-articles/news-articles/2025/12/this-week-at-fda-makary-teases-plan-for-single-tri Regulatory Focus en 2025-12-05 This Week at FDA: Makary teases plan for single-trial drug approvals, Høeg named acting CDER chief, and more https://www.raps.org/news-and-articles/news-articles/2025/12/fda-official-cder-warning-letters-up-50-in-fy-2025 Regulatory Focus en 2025-12-04 FDA official: CDER warning letters up 50 in FY 2025 https://www.raps.org/news-and-articles/news-articles/2025/12/recon-fda-to-reduce-number-of-studies-needed-for-m Regulatory Focus en 2025-12-04 Recon: FDA to reduce number of studies needed for most drugs CDC advisers delay vote on hepatitis B vaccine https://www.raps.org/news-and-articles/news-articles/2025/12/euro-roundup-commission-declares-eudamed-modules-f Regulatory Focus en 2025-12-04 Euro Roundup: Commission declares Eudamed modules functional, starting countdown https://www.raps.org/news-and-articles/news-articles/2025/12/bsufa-industry-seeks-enhancements-for-next-biosimi Regulatory Focus en 2025-12-03 BsUFA: Industry seeks enhancements for next biosimilars program https://www.raps.org/news-and-articles/news-articles/2025/12/fda-guidance-would-cut-back-on-using-monkeys-for-s Regulatory Focus en 2025-12-02 FDA guidance would cut back on using monkeys for safety testing of monoclonal antibodies https://www.raps.org/news-and-articles/news-articles/2025/12/ema-considers-new-biomarkers,-patient-populations Regulatory Focus en 2025-12-02 EMA considers new biomarkers, patient populations in proposed Parkinsons disease guideline update https://www.raps.org/news-and-articles/news-articles/2025/12/recon-pazdur-to-retire-from-fda-weeks-after-taking Regulatory Focus en 2025-12-02 Recon: Pazdur to retire from FDA weeks after taking CDER job CDC advisors to vote on delaying hep B vaccine https://www.raps.org/news-and-articles/news-articles/2025/12/recon-uk,-us-ink-deal-for-zero-tariffs-on-pharma-p Regulatory Focus en 2025-12-01 Recon: UK, US ink deal for zero-tariffs on pharma products EUDAMED notice heralds new era of compliance https://www.raps.org/news-and-articles/news-articles/2025/12/fda-issues-draft-guidance-to-help-medical-gas-manu Regulatory Focus en 2025-12-01 FDA issues draft guidance to help medical gas manufacturers comply with new tailored GMPs https://www.raps.org/news-and-articles/news-articles/2025/12/commenters-seek-details-on-rmat-designation Regulatory Focus en 2025-12-01 Commenters seek details on RMAT designation https://www.raps.org/news-and-articles/news-articles/2025/12/asia-pacific-roundup-australia-s-tga-seeks-feedbac Regulatory Focus en 2025-12-01 Asia-Pacific Roundup: Australias TGA seeks feedback on planned adoption of 23 international guidelines https://www.raps.org/news-and-articles/news-articles/2025/11/ich-announces-new-topics,-adopts-harmonized-templa Regulatory Focus en 2025-11-26 ICH announces new topics, adopts harmonized template for clinical trial protocols https://www.raps.org/news-and-articles/news-articles/2025/11/fda-allows-reformulated-ranitidine-back-on-the-mar Regulatory Focus en 2025-11-26 FDA allows reformulated ranitidine back on the market https://www.raps.org/news-and-articles/news-articles/2025/11/fda-guidance-outlines-where-to-send-cross-center” Regulatory Focus en 2025-11-25 FDA guidance outlines where to send cross-center master files https://www.raps.org/news-and-articles/news-articles/2025/11/commenters-call-for-fda-to-loosen-trial-requiremen Regulatory Focus en 2025-11-25 Commenters ask FDA to allow rare disease classification for disseminated coccidioidomycosis drugs https://www.raps.org/news-and-articles/news-articles/2025/11/gastroenterology-group-asks-fda-for-more-discussio Regulatory Focus en 2025-11-25 Gastroenterology group asks FDA for more discussion on GERD guidances https://www.raps.org/news-and-articles/news-articles/2025/11/recon-hta-regulation-pico-consolidation-goes-well; Regulatory Focus en 2025-11-25 Recon: HTA regulation: PICO consolidation goes well US commission seeks research infrastructure revamp https://www.raps.org/news-and-articles/news-articles/2025/11/safety-label-guidance-commenters-want-clarity-tran Regulatory Focus en 2025-11-24 Safety label guidance: Commenters want clarity, transparency, and assurances https://www.raps.org/news-and-articles/news-articles/2025/11/fda-warning-letters-target-two-firms-in-india-for Regulatory Focus en 2025-11-24 FDA warning letters target two firms in India for GMP violations, US sponsor for BIMO violations https://www.raps.org/news-and-articles/news-articles/2025/11/recon-lilly-hits-$1-trillion-valuation;-notified-b Regulatory Focus en 2025-11-24 Recon: Lilly hits 1 trillion valuation Notified bodies have capacityfor now https://www.raps.org/news-and-articles/news-articles/2025/11/asia-pacific-roundup-pmda-posts-points-to-consider Regulatory Focus en 2025-11-24 Asia-Pacific Roundup: PMDA posts points to consider for psoriatic arthritis clinical trials https://www.raps.org/news-and-articles/news-articles/2025/11/study-fda-finds-competitive-generic-therapies-laun Regulatory Focus en 2025-11-21 Study: FDA finds competitive generic therapies launch faster than other generics https://www.raps.org/news-and-articles/news-articles/2025/11/this-week-reports-of-tension-between-rfk-and-makar Regulatory Focus en 2025-11-21 This Week: Reports of tension between RFK and Makary, concerns about CNPV, and more https://www.raps.org/news-and-articles/news-articles/2025/11/fda-official-agency-ironing-out-the-details-of-pla Regulatory Focus en 2025-11-21 FDA official: Agency ironing out the details of plausible mechanism pathway https://www.raps.org/news-and-articles/news-articles/2025/11/ocp-chief-reassures-stakeholders-on-eddo-guidance Regulatory Focus en 2025-11-20 OCP chief reassures stakeholders on EDDO guidance https://www.raps.org/news-and-articles/news-articles/2025/11/stakeholders-weigh-in-on-fda-s-draft-clinical-outc Regulatory Focus en 2025-11-20 Stakeholders weigh in on FDAs draft clinical outcome assessment template https://www.raps.org/news-and-articles/news-articles/2025/11/euro-roundup-ema-outlines-processes-for-accelerati Regulatory Focus en 2025-11-20 Euro Roundup: EMA outlines processes for accelerating drug development in health emergencies https://www.raps.org/news-and-articles/news-articles/2025/11/recon-abbott-to-acquire-exact-sciences-in-$21b-dea Regulatory Focus en 2025-11-20 Recon: Abbott to acquire Exact Sciences in 21B deal Merck KGaA pairs with Valo for AI drug discovery https://www.raps.org/news-and-articles/news-articles/2025/11/experts-pccps-can-advance-ai-in-combination-produc Regulatory Focus en 2025-11-19 Experts: PCCPs can advance AI in combination products, be aware of state laws https://www.raps.org/news-and-articles/news-articles/2025/11/developments-in-us-trade-policy-affecting-the-diet Regulatory Focus en 2025-11-19 Developments in US trade policy affecting the dietary supplement industry https://www.raps.org/news-and-articles/news-articles/2025/11/fda-finalizes-guidance-on-patient-focused-drug-dev Regulatory Focus en 2025-11-18 FDA finalizes guidance on patient-focused drug development https://www.raps.org/news-and-articles/news-articles/2025/11/recon-csl-to-invest-1-5b-on-us-drug-production-f Regulatory Focus en 2025-11-18 Recon: CSL to invest 15B on US drug production FDA approves Arrowheads Redemplo for rare genetic disorder https://www.raps.org/news-and-articles/news-articles/2025/11/influencer-advertising-of-food-supplements Regulatory Focus en 2025-11-18 Influencer advertising of food supplements https://www.raps.org/news-and-articles/news-articles/2025/11/fda-finalizes-guidance-on-criteria-for-granting-wa Regulatory Focus en 2025-11-17 FDA finalizes guidance on criteria for granting waiver requests for pH adjusters https://www.raps.org/news-and-articles/news-articles/2025/11/astrazeneca-lands-opdp-untitled-letter-over-farxig Regulatory Focus en 2025-11-17 AstraZeneca lands OPDP untitled letter over Farxiga TV ad https://www.raps.org/news-and-articles/news-articles/2025/11/asia-pacific-roundup-tga-seeks-feedback-on-changes Regulatory Focus en 2025-11-17 Asia-Pacific Roundup: TGA seeks feedback on changes to medicinal maggot regulation https://www.raps.org/news-and-articles/news-articles/2025/11/recon-j-j-boosts-cancer-portfolio-with-$3-05b-hald Regulatory Focus en 2025-11-17 Recon: JJ boosts cancer portfolio with 305B Halda acquisition RFK Jr reportedly discussed scaling back Makarys role at FDA https://www.raps.org/news-and-articles/news-articles/2025/11/read-crls,-review-documents-for-human-factors-insi Regulatory Focus en 2025-11-14 Read CRLs, review documents for human factors insights, experts say https://www.raps.org/news-and-articles/news-articles/2025/11/this-week-at-the-fda-new-cder-director,-end-of-the Regulatory Focus en 2025-11-14 This week at the FDA: New CDER director, end of the shutdown, and more https://www.raps.org/news-and-articles/news-articles/2025/11/fda-leaders-propose-new-‘plausible-mechanism-pathw Regulatory Focus en 2025-11-13 FDA leaders propose new plausible mechanism pathway for bespoke medicines https://www.raps.org/news-and-articles/news-articles/2025/11/ocp-director-office-continues-to-operate-normally Regulatory Focus en 2025-11-13 OCP director: Office continues to operate normally despite staff losses https://www.raps.org/news-and-articles/news-articles/2025/11/euro-roundup-eu-countries-start-piloting-coordinat Regulatory Focus en 2025-11-13 Euro Roundup: EU countries start piloting coordinated reviews of medtech clinical trial filings https://www.raps.org/news-and-articles/news-articles/2025/11/recon-fda-approves-kura-kyowa-blood-cancer-drug-p Regulatory Focus en 2025-11-13 Recon: FDA approves Kura-Kyowa blood cancer drug Pfizer completes Metsera acquisition https://www.raps.org/news-and-articles/news-articles/2025/11/fda-issues-slew-of-warning-letters-for-gmp-and-una Regulatory Focus en 2025-11-12 FDA issues slew of warning letters for GMP and unapproved drug violations https://www.raps.org/news-and-articles/news-articles/2025/11/pazdur-takes-helm-at-cder-after-tidmarsh-departure Regulatory Focus en 2025-11-11 Pazdur takes helm at CDER after Tidmarsh departure https://www.raps.org/news-and-articles/news-articles/2025/11/experts-look-for-relief-from-eu-ai-act-for-medtech Regulatory Focus en 2025-11-11 Experts look for relief from EU AI Act for medtech industry https://www.raps.org/news-and-articles/news-articles/2025/11/medical-groups-make-recommendations-for-fda-regula Regulatory Focus en 2025-11-11 Medical groups make recommendations for FDA regulation of genAI mental health devices https://www.raps.org/news-and-articles/news-articles/2025/11/recon-novo-nordisk-to-slash-wegovy-price-by-as-muc Regulatory Focus en 2025-11-11 Recon: Novo Nordisk to slash Wegovy price by as much as 37 in India Neurocrine depression therapy fails in mid-stage study https://www.raps.org/news-and-articles/news-articles/2025/11/fda-questions-on-genai-enabled-chatbots-raise-conc Regulatory Focus en 2025-11-10 FDA questions on genAI-enabled chatbots raise concerns from expert panel https://www.raps.org/news-and-articles/news-articles/2025/11/expert-ai-compliance-in-eu-requires-proactive-life Regulatory Focus en 2025-11-10 Expert: AI compliance in EU requires proactive lifecycle management approach https://www.raps.org/news-and-articles/news-articles/2025/11/fda-to-remove-boxed-warnings-from-hormone-therapie Regulatory Focus en 2025-11-10 FDA to remove boxed warnings from hormone therapies for menopause https://www.raps.org/news-and-articles/news-articles/2025/11/asia-pacific-roundup-china-updates-gmps-for-medica Regulatory Focus en 2025-11-10 Asia-Pacific Roundup: China updates GMPs for medical devices, starts 1-year transition to new rules https://www.raps.org/news-and-articles/news-articles/2025/11/recon-metsera-plunges-after-accepting-pfizer-s-$10 Regulatory Focus en 2025-11-10 Recon: Metsera plunges after accepting Pfizers 10B offer Eli Lilly partners with MeiraGTxs for eye disease gene therapy https://www.raps.org/news-and-articles/news-articles/2025/11/this-week-at-fda-tidmarsh-saga-unfolds-another-ba Regulatory Focus en 2025-11-07 This Week at FDA: Tidmarsh saga unfolds, another batch of Commissioners vouchers, and more https://www.raps.org/news-and-articles/news-articles/2025/11/fda-updates-pre-rfd-guidance-with-new-recommendati Regulatory Focus en 2025-11-07 FDA updates Pre-RFD guidance with new recommendations https://www.raps.org/news-and-articles/news-articles/2025/11/makary-says-fda-is-‘strong-despite-recent-leadersh Regulatory Focus en 2025-11-06 Makary says FDA is strong despite recent leadership turmoil https://www.raps.org/news-and-articles/news-articles/2025/11/recon-ftc-expresses-concern-over-novo-nordisk-s-de Regulatory Focus en 2025-11-06 Recon: FTC expresses concern over Novo Nordisks desire to buy Metsera FDA OKs Caplyta as a add-on depression treatment https://www.raps.org/news-and-articles/news-articles/2025/11/euro-roundup-mhra-commits-to-major-reform-of-rare Regulatory Focus en 2025-11-06 Euro Roundup: MHRA commits to major reform of rare disease therapy regulation https://www.raps.org/news-and-articles/news-articles/2025/11/vagueness-of-article-10a-is-cause-for-concern Regulatory Focus en 2025-11-05 Vagueness of Article 10a is cause for concern https://www.raps.org/news-and-articles/news-articles/2025/11/pharma-groups-seek-expansion-of-fda-s-precheck-pro Regulatory Focus en 2025-11-04 Pharma groups seek expansion of FDAs PreCheck program https://www.raps.org/news-and-articles/news-articles/2025/11/experts-ai-tools-can-reduce-the-clinical-evaluatio Regulatory Focus en 2025-11-04 Experts: AI tools can reduce the clinical evaluation workload for medtech firms https://www.raps.org/news-and-articles/news-articles/2025/11/recon-pfizer-novo-escalate-bidding-war-over-metse Regulatory Focus en 2025-11-04 Recon: Pfizer, Novo escalate bidding war over Metsera Merck lands 700M from Blackstone to develop investigational cancer drug https://www.raps.org/news-and-articles/news-articles/2025/11/fda-issues-draft-guidance-on-qmsr-information-for Regulatory Focus en 2025-11-03 FDA issues draft guidance on QMSR information for premarket submissions https://www.raps.org/news-and-articles/news-articles/2025/11/asia-pacific-roundup-malaysia-accepts-fda-medtech Regulatory Focus en 2025-11-03 Asia-Pacific Roundup: Malaysia accepts FDA medtech approvals under reciprocal trade agreement https://www.raps.org/news-and-articles/news-articles/2025/11/lessons-to-keep-key-learnings-from-regulatory-proj Regulatory Focus en 2025-11-03 Lessons to keep: Key learnings from regulatory project managers https://www.raps.org/news-and-articles/news-articles/2025/11/recon-tidmarsh-resigns-as-cder-chief-amid-inquiry Regulatory Focus en 2025-11-03 Recon: Tidmarsh resigns as CDER chief amid inquiry, lawsuit Kimberly-Clark to buy Tylenol maker Kenvue for 40B https://www.raps.org/news-and-articles/news-articles/2025/11/novel-foods-classification-an-eu-and-global-perspe Regulatory Focus en 2025-11-01 Novel foods classification: An EU and global perspective https://www.raps.org/news-and-articles/news-articles/2025/11/journal-of-regulatory-affairs-a-guide-for-submitti Regulatory Focus en 2025-11-01 Journal of Regulatory Affairs: A guide for submitting articles https://www.raps.org/news-and-articles/news-articles/2025/10/this-week-at-fda-biosimilar-updates-fda-staff-cha Regulatory Focus en 2025-10-31 This week at FDA: Biosimilar updates, FDA staff changes, and more https://www.raps.org/news-and-articles/news-articles/2025/10/treat-ai-act-as-part-of-eu-regulatory-lasagna-for Regulatory Focus en 2025-10-31 Treat AI Act as part of EU regulatory lasagna for devices, expert says https://www.raps.org/news-and-articles/news-articles/2025/10/trends-and-developments-in-dietary-supplement-clas Regulatory Focus en 2025-10-31 Trends and developments in dietary supplement class action lawsuits in the US https://www.raps.org/news-and-articles/news-articles/2025/10/embrace-ai-in-regulatory-but-ensure-humans-are-i Regulatory Focus en 2025-10-30 Embrace AI in regulatory, but ensure humans are in the loop, experts say https://www.raps.org/news-and-articles/news-articles/2025/10/euro-roundup-ema-seeks-feedback-on-reducing-the-us Regulatory Focus en 2025-10-30 Euro Roundup: EMA seeks feedback on reducing the use of non-human primates in safety testing https://www.raps.org/news-and-articles/news-articles/2025/10/recon-novo-nordisk-pfizer-make-dueling-offers-for Regulatory Focus en 2025-10-30 Recon: Novo Nordisk, Pfizer make dueling offers for obesity drugmaker Metsera Zepbound and Mounjaro top Keytruda as worlds top-selling drug https://www.raps.org/news-and-articles/news-articles/2025/10/fda-proposes-to-cut-comparative-efficacy-study-req Regulatory Focus en 2025-10-29 FDA proposes to cut comparative efficacy study requirements for most biosimilars https://www.raps.org/news-and-articles/news-articles/2025/10/notified-body-official-tell-a-product-s-story-when Regulatory Focus en 2025-10-29 Notified body official: Tell a products story when describing benefit-risk https://www.raps.org/news-and-articles/news-articles/2025/10/fda-official-issues-warning-about-looming-biosimil Regulatory Focus en 2025-10-28 FDA official issues warning about looming biosimilar void https://www.raps.org/news-and-articles/news-articles/2025/10/experts-hope-mdr-ivdr-reforms-will-improve-predic Regulatory Focus en 2025-10-28 Experts hope MDR, IVDR reforms will improve predictability, reduce burdens https://www.raps.org/news-and-articles/news-articles/2025/10/recon-lilly-produces-billions-of-weight-loss-pills Regulatory Focus en 2025-10-28 Recon: Lilly produces billions of weight-loss pills ahead of FDA approval Philips gets FDA warning letter over issues at 3 facilities https://www.raps.org/news-and-articles/news-articles/2025/10/fda-s-top-generic-drug-official-urges-firms-to-com Regulatory Focus en 2025-10-27 FDAs top generic drug official urges firms to complete nitrosamine risk assessments https://www.raps.org/news-and-articles/news-articles/2025/10/recon-novartis-to-buy-rna-developer-avidity-in-$12 Regulatory Focus en 2025-10-27 Recon: Novartis to buy RNA developer Avidity in 12B deal Intellia halts gene therapy trials following patient liver injury https://www.raps.org/news-and-articles/news-articles/2025/10/asia-pacific-roundup-india-s-cdsco-seeks-feedback Regulatory Focus en 2025-10-27 Asia-Pacific Roundup: Indias CDSCO seeks feedback on medical device software regulation https://www.raps.org/news-and-articles/news-articles/2025/10/this-week-at-fda-new-guidance,-shutdown-pay-issues Regulatory Focus en 2025-10-24 This Week at FDA: New guidance, shutdown pay issues, and another inspection overhaul https://www.raps.org/news-and-articles/news-articles/2025/10/fda-warns-chinese-and-swiss-device-makers-over-qua Regulatory Focus en 2025-10-24 FDA warns Chinese and Swiss device makers over quality system violations https://www.raps.org/news-and-articles/news-articles/2025/10/drugmakers-seek-greater-leeway-in-radiopharmaceuti Regulatory Focus en 2025-10-24 Drugmakers seek greater leeway in radiopharmaceutical dosing guidance https://www.raps.org/news-and-articles/news-articles/2025/10/fda-publishes-nda-filing-checklist-to-avoid-applic Regulatory Focus en 2025-10-23 FDA publishes NDA filing checklist to avoid application derailments https://www.raps.org/news-and-articles/news-articles/2025/10/euro-roundup-notified-bodies-highlight-issue-that Regulatory Focus en 2025-10-23 Euro Roundup: Notified bodies highlight issue that could massively hinder AI regulation https://www.raps.org/news-and-articles/news-articles/2025/10/recon-moderna-ends-development-of-cmv-vaccine-icer Regulatory Focus en 2025-10-23 Recon: Moderna ends development of CMV vaccine ICER finds launch prices for drugs significantly higher than inflation https://www.raps.org/news-and-articles/news-articles/2025/10/stakeholders-ask-for-flexibility,-more-examples-in Regulatory Focus en 2025-10-22 Stakeholders ask for flexibility, more examples in FDA guidance on overall survival in cancer trials https://www.raps.org/news-and-articles/news-articles/2025/10/fda-s-drug-and-biologics-centers-report-steep-drop Regulatory Focus en 2025-10-22 FDAs drug and biologics centers report steep drop in headcount in FY 2025 https://www.raps.org/news-and-articles/news-articles/2025/10/ema-partners-with-instagram-influencers-to-counter Regulatory Focus en 2025-10-21 EMA partners with Instagram influencers to counter GLP-1 misinformation https://www.raps.org/news-and-articles/news-articles/2025/10/fda-warns-us-and-australian-eye-drop-companies-for Regulatory Focus en 2025-10-21 FDA warns US and Australian eye drop companies for GMP violations, making unapproved claims https://www.raps.org/news-and-articles/news-articles/2025/10/fda-officials-high-quality-data-is-essential-for-a Regulatory Focus en 2025-10-21 FDA officials: High-quality data is essential for AI tools for generic drugs https://www.raps.org/news-and-articles/news-articles/2025/10/convergence-regulators-experts-weigh-dedicated-pa Regulatory Focus en 2025-10-21 Convergence: Regulators, experts weigh dedicated patient experience section in drug labels https://www.raps.org/news-and-articles/news-articles/2025/10/recon-cbo-estimates-orphan-drug-exemptions-will-co Regulatory Focus en 2025-10-21 Recon: CBO estimates orphan drug exemptions will cost Medicare 39B Blackstone, TPG take Hologic private in 183B deal https://www.raps.org/news-and-articles/news-articles/2025/10/convergence-new-ich-q1-guideline-is-one-stop-shop Regulatory Focus en 2025-10-20 Convergence: New ICH Q1 guideline is one-stop shop for stability testing https://www.raps.org/news-and-articles/news-articles/2025/10/sbom-tools-are-still-new-but-useful-say-experts Regulatory Focus en 2025-10-20 Experts offer tips on assembling SBOMs for medical devices https://www.raps.org/news-and-articles/news-articles/2025/10/fda-announces-first-round-recipients-of-national-p Regulatory Focus en 2025-10-20 FDA announces first-round recipients of national priority voucher program https://www.raps.org/news-and-articles/news-articles/2025/10/asia-pacific-roundup-australia-s-tga-proposes-temp Regulatory Focus en 2025-10-20 Asia-Pacific Roundup: Australias TGA proposes temporary GMP exemption to help bacteriophage developers https://www.raps.org/news-and-articles/news-articles/2025/10/recon-fda-approves-glaukos-eye-treatment-merck-to Regulatory Focus en 2025-10-20 Recon: FDA approves Glaukos eye treatment Merck to invest 70B in US research and manufacturing https://www.raps.org/news-and-articles/news-articles/2025/10/the-impact-of-us-state-law-initiatives-for-food-in Regulatory Focus en 2025-10-17 The impact of US state law initiatives for food ingredients on the food industry https://www.raps.org/news-and-articles/news-articles/2025/10/this-week-at-fda-lawmakers-look-to-fund-fda,-hhs-s Regulatory Focus en 2025-10-16 This Week at FDA: Lawmakers look to fund FDA, HHS shutdown RIF, and more https://www.raps.org/news-and-articles/news-articles/2025/10/convergence-think-win-win-during-early-orientatio Regulatory Focus en 2025-10-16 Convergence: Think win-win during early orientation meetings with FDA for digital health devices https://www.raps.org/news-and-articles/news-articles/2025/10/euro-roundup-notified-bodies-propose-steps-to-end Regulatory Focus en 2025-10-16 Euro Roundup: Notified bodies propose steps to end lengthy debates over MDR evidence rules https://www.raps.org/news-and-articles/news-articles/2025/10/recon-roche-to-market-50-flu-pill-to-us-cash-buye Regulatory Focus en 2025-10-16 Recon: Roche to market 50 flu pill to US cash buyers Praxis surges on positive results from shaking disorder trials https://www.raps.org/news-and-articles/news-articles/2025/10/mhra-s-tallon-says-agency-wants-risk-proportionate Regulatory Focus en 2025-10-15 MHRAs Tallon says agency wants risk-proportionate device, AI regulation https://www.raps.org/news-and-articles/news-articles/2025/10/convergence-fda,-industry-experts-lead-way-on-pati Regulatory Focus en 2025-10-15 Convergence: FDA, industry experts lead way on patient experience data https://www.raps.org/news-and-articles/news-articles/2025/10/convergence-industry-veterans-share-lessons-learne Regulatory Focus en 2025-10-14 Convergence: Industry veterans share lessons learned from jumping CDx hurdles https://www.raps.org/news-and-articles/news-articles/2025/10/medtech-expert-hopeful-about-eu-mdr-ivdr-reforms Regulatory Focus en 2025-10-14 Medtech expert hopeful about EU MDRIVDR reforms https://www.raps.org/news-and-articles/news-articles/2025/10/fda-warns-lifevac-for-marketing-unauthorized-anti Regulatory Focus en 2025-10-14 FDA warns LifeVac for marketing unauthorized anti-choking device https://www.raps.org/news-and-articles/news-articles/2025/10/recon-fda-career-staff-say-political-pressure-is-a Regulatory Focus en 2025-10-14 Recon: FDA career staff say political pressure is affecting their jobs Supreme Court rejects bid to weigh in on FDA stem cell regulation https://www.raps.org/news-and-articles/news-articles/2025/10/using-ahp-to-guide-regulatory-strategy-for-dietary Regulatory Focus en 2025-10-14 Using AHP to guide regulatory strategy for dietary supplements https://www.raps.org/news-and-articles/news-articles/2025/10/convergence-fda-officials-tout-open-door-policy-fo Regulatory Focus en 2025-10-13 Convergence: FDA officials tout open door policy for ACNU nonprescription pathway https://www.raps.org/news-and-articles/news-articles/2025/10/who-raises-alert-over-deg-contaminated-cough-syrup Regulatory Focus en 2025-10-13 WHO raises alert over DEG-contaminated cough syrups in India https://www.raps.org/news-and-articles/news-articles/2025/10/pccps-sponsors-should-engage-early,-ensure-they-ne Regulatory Focus en 2025-10-13 PCCPs: Sponsors should engage early, ensure they need the change, be specific https://www.raps.org/news-and-articles/news-articles/2025/10/convergence-experts-look-for-greater-international Regulatory Focus en 2025-10-13 Convergence: Experts look for greater international alignment on combination products https://www.raps.org/news-and-articles/news-articles/2025/10/asia-pacific-roundup-india-s-cdsco-calls-for-stric Regulatory Focus en 2025-10-13 Asia-Pacific Roundup: CDSCO seeks feedback how to ensure a level playing field for drug approvals https://www.raps.org/news-and-articles/news-articles/2025/10/recon-fda-labels-novo-s-indiana-plant-out-of-compl Regulatory Focus en 2025-10-13 Recon: FDA labels Novos Indiana plant out of compliance WHO warns of surging antibiotic resistance https://www.raps.org/news-and-articles/news-articles/2025/10/this-week-at-fda-more-layoffs-at-hhs-prasad-s-cbe Regulatory Focus en 2025-10-10 This week at FDA: More layoffs at HHS, Prasads CBER hires, and Peter Marks joins Eli Lilly https://www.raps.org/news-and-articles/news-articles/2025/10/tarver-cdrh-on-track-to-meet-mdufa-metrics-despite Regulatory Focus en 2025-10-10 Tarver: CDRH on track to meet MDUFA metrics despite personnel losses https://www.raps.org/news-and-articles/news-articles/2025/10/raps-convergence-2025-recap Regulatory Focus en 2025-10-09 RAPS Convergence 2025 hosts the worlds largest regulatory affairs gathering https://www.raps.org/news-and-articles/news-articles/2025/10/convergence-notified-bodies-provide-proposals-for Regulatory Focus en 2025-10-09 Convergence: Notified bodies provide proposals for MDRIVDR changes https://www.raps.org/news-and-articles/news-articles/2025/10/medtech-industry-calls-for-major-reforms-to-mdr-an Regulatory Focus en 2025-10-09 Medtech industry calls for major reforms to MDR and IVDR https://www.raps.org/news-and-articles/news-articles/2025/10/convergence-regulators,-experts-weigh-fixes-for-or Regulatory Focus en 2025-10-09 Convergence: Regulators, experts weigh fixes for orphan device challenges https://www.raps.org/news-and-articles/news-articles/2025/10/euro-roundup-ema-opens-door-to-reliance-on-fda-gmp Regulatory Focus en 2025-10-09 Euro Roundup: EMA opens door to reliance on FDA GMP inspections conducted outside the US https://www.raps.org/news-and-articles/news-articles/2025/10/recon-novo-to-purchase-akero-for-up-to-$5-2b;-indi Regulatory Focus en 2025-10-09 Recon: Novo to purchase Akero for up to 52B Indian police make arrest in cough syrup deaths case https://www.raps.org/news-and-articles/news-articles/2025/10/convergence-eu-regulators-offer-advice-on-innovati Regulatory Focus en 2025-10-08 Convergence: EU regulators offer tips for innovative product development https://www.raps.org/news-and-articles/news-articles/2025/10/convergence-‘get-ready-to-use-genai-in-drug-develo Regulatory Focus en 2025-10-08 Convergence: Get ready to use genAI in drug development https://www.raps.org/news-and-articles/news-articles/2025/10/strong-medical-device-cybersecurity-can-be-a-marke Regulatory Focus en 2025-10-08 Strong medical device cybersecurity can be a market differentiator, experts say https://www.raps.org/news-and-articles/news-articles/2025/10/2025-convergence-plenary Regulatory Focus en 2025-10-07 Convergence: Rebuilding public trust in science with empathy, transparency https://www.raps.org/news-and-articles/news-articles/2025/10/fda-warning-letters-cite-us-firms-over-inadequate Regulatory Focus en 2025-10-07 FDA warns US firms over inadequate testing, lax process controls https://www.raps.org/news-and-articles/news-articles/2025/10/experts-ai-can-enhance-clinical-trial-participant Regulatory Focus en 2025-10-07 Experts: AI can enhance clinical trial participant selection https://www.raps.org/news-and-articles/news-articles/2025/10/recon-peter-marks-joins-eli-lilly-to-head-infectio Regulatory Focus en 2025-10-07 Recon: Peter Marks joins Eli Lilly to head infectious disease unit AstraZeneca blood pressure drug hit main goal in Phase 3 trial https://www.raps.org/news-and-articles/news-articles/2025/10/fda-seeks-input-on-evaluating-ai-enabled-medical-d Regulatory Focus en 2025-10-06 FDA seeks input on evaluating AI-enabled medical devices https://www.raps.org/news-and-articles/news-articles/2025/10/convergence-2025-adapting-to-change-and-uncertaint Regulatory Focus en 2025-10-06 Convergence 2025: Adapting to change and uncertainty in the regulatory landscape https://www.raps.org/news-and-articles/news-articles/2025/10/recon-cdc-approves-new-covid-vaccine-recommendatio Regulatory Focus en 2025-10-06 Recon: CDC approves new COVID vaccine recommendations AstraZeneca licenses Algen AI gene-editing platform for 555M https://www.raps.org/news-and-articles/news-articles/2025/10/asia-pacific-roundup-hsa-partners-with-trade-group Regulatory Focus en 2025-10-06 Asia-Pacific Roundup: HSA partners with trade group to support Singapores medtech industry https://www.raps.org/news-and-articles/news-articles/2025/10/this-week-at-fda-anda-prioritization-pilot;-cdrh-g Regulatory Focus en 2025-10-03 This week at FDA: ANDA prioritization pilot CDRH guidance priorities, and more https://www.raps.org/news-and-articles/news-articles/2025/10/researchers-recommend-us-diversify-antibiotic-impo Regulatory Focus en 2025-10-03 Researchers recommend US diversify antibiotic imports to reduce shortages https://www.raps.org/news-and-articles/news-articles/2025/10/euro-roundup-joint-hma-ema-group-starts-consultati Regulatory Focus en 2025-10-02 Euro Roundup: Joint HMA-EMA group starts consultation into priorities for AI in research and regulation https://www.raps.org/news-and-articles/news-articles/2025/10/recon-fda-rejects-fortress-zydus-menkes-disease-d Regulatory Focus en 2025-10-02 Recon: FDA rejects Fortress, Zydus Menkes disease drug over GMP concerns Jazz wins expanded FDA approval for lung cancer combo https://www.raps.org/news-and-articles/news-articles/2025/10/shutdown-fda-will-not-accept-submissions-until-fun Regulatory Focus en 2025-10-01 Shutdown: FDA will not accept submissions requiring fees until funding resumes https://www.raps.org/news-and-articles/news-articles/2025/10/fda-lists-its-upcoming-research-priorities-for-gen Regulatory Focus en 2025-10-01 FDA lists its upcoming research priorities for generic drugs https://www.raps.org/news-and-articles/news-articles/2025/9/onshoring-stakeholders-seek-enhancements-to-fda-s Regulatory Focus en 2025-09-30 Onshoring: Drugmakers seek enhancements to FDAs PreCheck program https://www.raps.org/news-and-articles/news-articles/2025/9/recon-trump-says-pfizer-will-cut-us-prices;-sanofi Regulatory Focus en 2025-09-30 Recon: Trump says Pfizer will cut US prices Sanofi targeted in EU vaccine antitrust investigation https://www.raps.org/news-and-articles/news-articles/2025/9/imdrf-plans-new-pccp-guideline,-adds-new-affiliate Regulatory Focus en 2025-09-30 IMDRF plans new PCCP guideline, adds new affiliates https://www.raps.org/news-and-articles/news-articles/2025/9/rf-quarterly,-september-2025-global-regulatory-har Regulatory Focus en 2025-09-30 RF Quarterly, September 2025: Global regulatory harmonization https://www.raps.org/news-and-articles/news-articles/2025/9/ectd-v4-0-analysis-based-on-first-experiences-in-t Regulatory Focus en 2025-09-30 eCTD v40 analysis based on first experiences in the US and Japan https://www.raps.org/news-and-articles/news-articles/2025/9/quality-without-borders-a-decade-of-global-progres Regulatory Focus en 2025-09-30 Quality without borders: A decade of global progress in medical device standards harmonization https://www.raps.org/news-and-articles/news-articles/2025/9/global-harmonization-of-medical-device-postmarket Regulatory Focus en 2025-09-30 Global harmonization of medical device postmarket surveillance https://www.raps.org/news-and-articles/news-articles/2025/9/global-regulatory-harmonization-for-medical-device Regulatory Focus en 2025-09-30 Global regulatory harmonization for medical devices https://www.raps.org/news-and-articles/news-articles/2025/9/regulatory-reliance-optimizing-resources-and-speed Regulatory Focus en 2025-09-30 Regulatory reliance: Optimizing resources and speeding patient access https://www.raps.org/news-and-articles/news-articles/2025/9/stakeholders-fda-combo-products-udi-guidance-is-in Regulatory Focus en 2025-09-29 Stakeholders: FDA combo products UDI guidance is inconsistent with regulation https://www.raps.org/news-and-articles/news-articles/2025/9/asia-pacific-roundup-malaysia-s-mda-joins-mdsap-as Regulatory Focus en 2025-09-29 Asia-Pacific Roundup: Malaysias MDA joins MDSAP as affiliate member https://www.raps.org/news-and-articles/news-articles/2025/9/ema-tells-sponsors-to-incorporate-patient-experien Regulatory Focus en 2025-09-29 EMA tells sponsors to incorporate patient experience across product lifecycle https://www.raps.org/news-and-articles/news-articles/2025/9/recon-phrma-launches-direct-to-consumer-drug-site Regulatory Focus en 2025-09-29 Recon: PhRMA launches direct-to-consumer drug site Shutdown would prompt HHS to furlough 41 of staff https://www.raps.org/news-and-articles/news-articles/2025/9/fda-official-clinical,-cmc-teams-should-be-on-the Regulatory Focus en 2025-09-26 FDA official: Clinical, CMC teams should be on the same page when developing CGTs https://www.raps.org/news-and-articles/news-articles/2025/9/this-week-at-fda-fda-s-autism-moves,-novartis-gets Regulatory Focus en 2025-09-26 This Week at FDA: FDAs autism moves, Novartis gets untitled letter over TV ad, and more https://www.raps.org/news-and-articles/news-articles/2025/9/fda-official-updates-on-advancing-rwe-program,-lis Regulatory Focus en 2025-09-25 FDA official updates on advancing RWE program, lists common reasons for rejection https://www.raps.org/news-and-articles/news-articles/2025/9/eu-regulators-set-targets-to-promote-european-clin Regulatory Focus en 2025-09-25 EU regulators set targets to promote European clinical trials https://www.raps.org/news-and-articles/news-articles/2025/9/euro-roundup-commission-acts-to-streamline-lifecyc Regulatory Focus en 2025-09-25 Euro Roundup: Commission acts to streamline lifecycle management of medicines https://www.raps.org/news-and-articles/news-articles/2025/9/recon-rfk-jr-launches-review-of-mifepristone-fda Regulatory Focus en 2025-09-25 Recon: RFK Jr launches review of mifepristone FDA approves Lillys advanced breast cancer drug https://www.raps.org/news-and-articles/news-articles/2025/9/fda-issues-guidances-on-cgt,-regenerative-medicine Regulatory Focus en 2025-09-25 FDA issues guidances on CGT, regenerative medicine development https://www.raps.org/news-and-articles/news-articles/2025/9/ich-adopts-e2d(r1)-guideline-on-post-approval-safe Regulatory Focus en 2025-09-24 ICH adopts E2DR1 guideline on post-approval safety data https://www.raps.org/news-and-articles/news-articles/2025/9/janssen-s-korean-facility-cited-for-gmp-violations Regulatory Focus en 2025-09-23 Janssens Korean facility cited for GMP violations https://www.raps.org/news-and-articles/news-articles/2025/9/fda-finalizes-device-production-and-quality-system Regulatory Focus en 2025-09-23 FDA finalizes device production and quality system software guidance https://www.raps.org/news-and-articles/news-articles/2025/9/gottlieb-calls-for-fda-reform,-investment-to-count Regulatory Focus en 2025-09-23 Gottlieb calls for FDA reform, investment to counter Chinese medical innovation https://www.raps.org/news-and-articles/news-articles/2025/9/recon-lilly-plans-6-5b-texas-api-site-moderna-says Regulatory Focus en 2025-09-23 Recon: Lilly plans 65B Texas API site Moderna says updated COVID jab induces strong immune response https://www.raps.org/news-and-articles/news-articles/2025/9/experts-recommend-increased-visibility-for-regulat Regulatory Focus en 2025-09-22 Experts recommend increased visibility for regulatory analysis of primary clinical trial data https://www.raps.org/news-and-articles/news-articles/2025/9/fda-finalizes-guidance-on-approval-of-ivds-during Regulatory Focus en 2025-09-22 FDA finalizes guidance on approval of IVDs during public health emergencies https://www.raps.org/news-and-articles/news-articles/2025/9/trialscope-using-ai-to-scale-real-world-data Regulatory Focus en 2025-09-22 TRIALSCOPE: Using AI to scale real-world data https://www.raps.org/news-and-articles/news-articles/2025/9/recon-pfizer-to-acquire-obesity-drugmaker-metsera Regulatory Focus en 2025-09-22 Recon: Pfizer to acquire obesity drugmaker Metsera for 49B Bristol Myers to launch schizophrenia therapy Cobenfy in UK at US price https://www.raps.org/news-and-articles/news-articles/2025/9/asia-pacific-roundup-india-unveils-pharmacovigilan Regulatory Focus en 2025-09-22 Asia-Pacific Roundup: India unveils pharmacovigilance awareness, reporting initiatives https://www.raps.org/news-and-articles/news-articles/2025/9/this-week-fda-revokes-ldt-rule,-monarez-warns-abou Regulatory Focus en 2025-09-19 This Week: FDA revokes LDT rule, Monarez warns about vaccine policies, Kennedy called to defend his decisions https://www.raps.org/news-and-articles/news-articles/2025/9/regulatory-science-opportunities-for-contamination Regulatory Focus en 2025-09-18 Regulatory science opportunities for contamination controls and sterility assurance https://www.raps.org/news-and-articles/news-articles/2025/9/safety-labeling-fda-proposes-updated-guidance-on-p Regulatory Focus en 2025-09-18 Safety labeling: FDA proposes updated guidance on postmarket changes https://www.raps.org/news-and-articles/news-articles/2025/9/euro-roundup-uk-to-consult-on-pharmacy-level-subst Regulatory Focus en 2025-09-18 Euro Roundup: UK to consult on pharmacy-level substitution to counter drug shortages https://www.raps.org/news-and-articles/news-articles/2025/9/fda-proposes-guidance-for-developing-drugs-for-dis Regulatory Focus en 2025-09-18 FDA proposes guidance for developing drugs for disseminated coccidioidomycosis https://www.raps.org/news-and-articles/news-articles/2025/9/recon-roche-to-buy-mash-biotech-89bio-for-$2-4b;-k Regulatory Focus en 2025-09-18 Recon: Roche to buy MASH biotech 89bio for 24B Kennedys ACIP weighs changes to childhood vaccines https://www.raps.org/news-and-articles/news-articles/2025/9/stakeholders-seek-clarity-from-fda-on-cancer-drug Regulatory Focus en 2025-09-17 Stakeholders seek clarity from FDA on cancer drug combo guidance https://www.raps.org/news-and-articles/news-articles/2025/9/fda-posts-more-than-100-warning-and-untitled-lette Regulatory Focus en 2025-09-16 FDA posts more than 100 warning and untitled letters in ad crackdown https://www.raps.org/news-and-articles/news-articles/2025/9/latin-america-roundup-four-more-argentinian-drugma Regulatory Focus en 2025-09-16 Latin America Roundup: Four more Argentinian drugmakers are shuttered https://www.raps.org/news-and-articles/news-articles/2025/9/fda-issues-draft-guidances-targeting-gerd-related Regulatory Focus en 2025-09-16 FDA issues draft guidances targeting GERD-related conditions https://www.raps.org/news-and-articles/news-articles/2025/9/recon-eli-lilly-selects-virginia-as-$5b-api-site Regulatory Focus en 2025-09-16 Recon: Eli Lilly selects Virginia as 5B API site CSL invests 117M in VarmX coagulation drug https://www.raps.org/news-and-articles/news-articles/2025/9/fda-researchers-find-promise-in-custom-medical-que Regulatory Focus en 2025-09-15 FDA researchers find promise in custom medical queries to identify safety signals https://www.raps.org/news-and-articles/news-articles/2025/9/recon-fda-takes-on-dtc-ads-going-after-hims-hers-k Regulatory Focus en 2025-09-15 Recon: FDA takes on DTC ads, going after Hims Hers Kennedy appoints 5 new ACIP members https://www.raps.org/news-and-articles/news-articles/2025/9/ich-adopts-the-m14-guideline-on-observational-stud Regulatory Focus en 2025-09-15 ICH adopts M14 guideline on observational studies https://www.raps.org/news-and-articles/news-articles/2025/9/asia-pacific-roundup-australia-s-tga-seeks-feedbac Regulatory Focus en 2025-09-15 Asia-Pacific Roundup: Australias TGA seeks feedback on paper leaflets for injectable medicines https://www.raps.org/news-and-articles/news-articles/2025/9/this-week-at-fda-fda-s-ad-crackdown,-abandoning-ad Regulatory Focus en 2025-09-12 This Week at FDA: FDAs ad crackdown, abandoning adcomms, and more https://www.raps.org/news-and-articles/news-articles/2025/9/fda-finalizes-guidance-on-alternative-inspection-t Regulatory Focus en 2025-09-12 FDA finalizes guidance on alternative inspection tools https://www.raps.org/news-and-articles/news-articles/2025/9/industry-suggests-changes-to-fda-s-cmc-readiness-p Regulatory Focus en 2025-09-11 Industry suggests changes to FDAs CMC readiness pilot https://www.raps.org/news-and-articles/news-articles/2025/9/euro-roundup-commission-consults-on-changes-to-mdr Regulatory Focus en 2025-09-11 Euro Roundup: Commission consults on changes to MDR, IVDR https://www.raps.org/news-and-articles/news-articles/2025/9/recon-prasad-regains-fda-chief-medical-and-scienti Regulatory Focus en 2025-09-11 Recon: Prasad regains FDA chief medical and scientific officer title FDA panel to review AI mental health devices https://www.raps.org/news-and-articles/news-articles/2025/9/fda-issues-guidance-on-non-opioid-drug-development Regulatory Focus en 2025-09-10 FDA issues guidance on non-opioid drug development for chronic pain https://www.raps.org/news-and-articles/news-articles/2025/9/fda-cracks-down-on-drugs-ads,-promises-to-end-adeq Regulatory Focus en 2025-09-10 FDA cracks down on drugs ads, promises to end adequate provision loophole https://www.raps.org/news-and-articles/news-articles/2025/9/biosimilars-fda-finalizes-supplement-classificatio Regulatory Focus en 2025-09-09 Biosimilars: FDA finalizes supplement classification guidance https://www.raps.org/news-and-articles/news-articles/2025/9/fda-warns-indian-drugmaker-over-quality-lapses-cl Regulatory Focus en 2025-09-09 FDA warns Indian drugmaker over quality lapses, clinical researcher for enrollment issues https://www.raps.org/news-and-articles/news-articles/2025/9/recon-novartis-to-buy-tourmaline-for-$1-4b;-trump Regulatory Focus en 2025-09-09 Recon: Novartis to buy Tourmaline for 14B Trump could offer carve-outs for pharma in future trade pacts https://www.raps.org/news-and-articles/news-articles/2025/9/fda-finalizes-guidance-on-therapeutic-protein-bios Regulatory Focus en 2025-09-08 FDA finalizes guidance on therapeutic protein biosimilars https://www.raps.org/news-and-articles/news-articles/2025/9/mdufa-vi-industry-health-care-groups-call-for-clar Regulatory Focus en 2025-09-08 MDUFA VI: Industry, health groups call for clarity on AI, regulatory science investment https://www.raps.org/news-and-articles/news-articles/2025/9/asia-pacific-roundup-india-proposes-notification-s Regulatory Focus en 2025-09-08 Asia-Pacific Roundup: India proposes notification system for starting clinical trials for certain drugs https://www.raps.org/news-and-articles/news-articles/2025/9/recon-biontech-bms-tout-positive-phase-2-readout-f Regulatory Focus en 2025-09-08 Recon: BioNTech, BMS tout positive Phase 2 readout for lung cancer FDA OKs trial of gene-edited pig kidneys for transplantation https://www.raps.org/news-and-articles/news-articles/2025/9/rac-rcc-regulatory-affairs-credentials-summer Regulatory Focus en 2025-09-08 These professionals earned their RAC or RCC credentials in summer 2025 https://www.raps.org/news-and-articles/news-articles/2025/9/fda-s-latest-regulatory-agenda-pulls-ldt-rule,-spe Regulatory Focus en 2025-09-05 FDAs latest regulatory agenda pulls LDT rule, spells out plans to issue a final rule on NDC https://www.raps.org/news-and-articles/news-articles/2025/9/this-week-at-fda-fda-to-scrutinize-co-administered Regulatory Focus en 2025-09-05 This Week at FDA: FDA to scrutinize co-administered vaccines, new CRLs, and a GLP-1 Green List https://www.raps.org/news-and-articles/news-articles/2025/9/kennedy-clashes-with-democrats-over-vaccine-polici Regulatory Focus en 2025-09-04 Kennedy clashes with lawmakers over vaccine policies, CDC firing https://www.raps.org/news-and-articles/news-articles/2025/9/fda-to-publish-crls-‘promptly-as-drugs-are-rejecte Regulatory Focus en 2025-09-04 FDA to publish CRLs promptly as drugs are rejected https://www.raps.org/news-and-articles/news-articles/2025/9/euro-roundup-european-commission-seeks-feedback-on Regulatory Focus en 2025-09-04 Euro Roundup: European Commission seeks feedback on planned changes to GMP guidelines https://www.raps.org/news-and-articles/news-articles/2025/9/recon-prasad-overruled-staff-on-covid-vaccine-elig Regulatory Focus en 2025-09-04 Recon: Prasad overruled staff on COVID vaccine eligibility Congo declares Ebola outbreak https://www.raps.org/news-and-articles/news-articles/2025/9/fda-launches-program-for-rare-diseases-targeting-‘ Regulatory Focus en 2025-09-03 FDA launches program for rare diseases targeting significant unmet need https://www.raps.org/news-and-articles/news-articles/2025/9/stakeholders-seek-changes-to-fda-s-mds-drug-develo Regulatory Focus en 2025-09-03 Stakeholders seek changes to FDAs MDS drug development guidance https://www.raps.org/news-and-articles/news-articles/2025/9/latin-america-roundup-mexico-brazil-draft-agreeme Regulatory Focus en 2025-09-02 Latin-America Roundup: Mexico, Brazil draft agreements on reliance measures https://www.raps.org/news-and-articles/news-articles/2025/9/fda-cites-drugmakers-and-testing-lab-for-cgmp-viol Regulatory Focus en 2025-09-02 FDA cites drugmakers and testing lab for CGMP violations https://www.raps.org/news-and-articles/news-articles/2025/9/most-distributors-met-dscsa-requirements-by-august Regulatory Focus en 2025-09-02 Most distributors met DSCSA requirements by August deadline https://www.raps.org/news-and-articles/news-articles/2025/9/recon-novartis-licenses-arrowhead-s-neuromuscular Regulatory Focus en 2025-09-02 Recon: Novartis licenses Arrowheads neuromuscular drug for up to 2B Paul Offit removed from FDAs VRBPAC https://www.raps.org/news-and-articles/news-articles/2025/9/asia-pacific-roundup-tga-moves-to-updated-pics-gmp Regulatory Focus en 2025-09-02 Asia-Pacific Roundup: TGA moves to updated PICS GMP guide, seeks feedback on AI changes https://www.raps.org/news-and-articles/news-articles/2025/8/this-week-cdc-director-fired,-fda-advances-new-mas Regulatory Focus en 2025-08-29 This Week: CDC director fired, FDA advances new MASH tool, CMC pilot extended https://www.raps.org/news-and-articles/news-articles/2025/8/experts-call-for-more-guidance-from-fda-on-registr Regulatory Focus en 2025-08-29 Experts call for more guidance from FDA on registries in oncology https://www.raps.org/news-and-articles/news-articles/2025/8/mhra-launches-pilot-program-to-test-automatic-chan Regulatory Focus en 2025-08-28 MHRA launches pilot program to test automatic changes to clinical trials https://www.raps.org/news-and-articles/news-articles/2025/8/fda-officials-explain-how-to-ensure-registries-gen Regulatory Focus en 2025-08-28 FDA officials explain how to ensure registries generate fit-for-purpose data https://www.raps.org/news-and-articles/news-articles/2025/8/recon-fda-approves-teva-s-generic-obesity-drug;-ke Regulatory Focus en 2025-08-28 Recon: FDA approves Tevas generic obesity drug Kennedy to testify on health agenda next week https://www.raps.org/news-and-articles/news-articles/2025/8/euro-roundup-uk-government,-pharma-industry-fail-t Regulatory Focus en 2025-08-28 Euro Roundup: UK government, pharma industry fail to agree on medicines payment scheme https://www.raps.org/news-and-articles/news-articles/2025/8/fda-approves-updated-covid-vaccines-with-restricti Regulatory Focus en 2025-08-27 FDA approves updated COVID vaccines with restrictions on their use https://www.raps.org/news-and-articles/news-articles/2025/8/fda-warns-companies-for-glp,-cgmp,-and-marketing-v Regulatory Focus en 2025-08-26 FDA warns companies for GLP, CGMP, and marketing violations https://www.raps.org/news-and-articles/news-articles/2025/8/industry-wants-clarity-on-scope-of-ich-stability-t Regulatory Focus en 2025-08-26 Industry wants clarity on scope of ICH stability testing guideline, timing of studies https://www.raps.org/news-and-articles/news-articles/2025/8/recon-lillys-obesity-pill-reduced-weight-blood-sug Regulatory Focus en 2025-08-26 Recon: Lillys obesity pill reduced weight, blood sugar in late-stage trial EU approves Gileads HIV PREP injection https://www.raps.org/news-and-articles/news-articles/2025/8/fda-s-cder-announces-updated-guidance-agenda-for-2 Regulatory Focus en 2025-08-25 FDAs CDER announces updated guidance agenda for 2025 https://www.raps.org/news-and-articles/news-articles/2025/8/fda-finalizes-guidance-on-using-animal-studies-to Regulatory Focus en 2025-08-25 FDA finalizes guidance on using animal studies to develop dental bone grafting devices https://www.raps.org/news-and-articles/news-articles/2025/8/expert-recommends-alternative-approaches-to-substi Regulatory Focus en 2025-08-25 Expert recommends alternative approaches to substitute for randomized trials for COVID vaccines https://www.raps.org/news-and-articles/news-articles/2025/8/recon-abbvie-to-purchase-gilgamesh-s-psychedelic-t Regulatory Focus en 2025-08-25 Recon: AbbVie to purchase Gilgameshs psychedelic therapy for potential 12B FDA pauses Valnevas chikungunya vaccine license https://www.raps.org/news-and-articles/news-articles/2025/8/asia-pacific-roundup-malaysia-and-singapore-start Regulatory Focus en 2025-08-25 Asia-Pacific Roundup: Malaysia and Singapore start pilot to fast-track medtech launches https://www.raps.org/news-and-articles/news-articles/2025/8/this-week-at-fda-investigation-reveals-extent-of-h Regulatory Focus en 2025-08-22 This Week at FDA: Investigation reveals extent of HHS RIFs, Makary updates on CNPV pilot, FDA to hold meeting on user fees https://www.raps.org/news-and-articles/news-articles/2025/8/majority-of-pharmaceutical-plants-located-in-disas Regulatory Focus en 2025-08-22 Majority of pharmaceutical plants located in disaster-prone areas, study shows https://www.raps.org/news-and-articles/news-articles/2025/8/groups-pressure-cms-to-speed-coverage-of-breakthro Regulatory Focus en 2025-08-21 Groups pressure CMS to speed coverage of breakthrough devices after FDA authorization https://www.raps.org/news-and-articles/news-articles/2025/8/euro-roundup-swissdamed-registration-module-goes-l Regulatory Focus en 2025-08-21 Euro Roundup: Swissdamed registration module goes live ahead of mandatory use https://www.raps.org/news-and-articles/news-articles/2025/8/recon-cvs-won-t-add-gilead-s-hiv-prep-jab-to-cover Regulatory Focus en 2025-08-21 Recon: CVS wont add Gileads HIV PREP jab to coverage lists JJ to make 2B investment in US drug manufacturing https://www.raps.org/news-and-articles/news-articles/2025/8/industry-and-consumer-groups-call-for-improved-rev Regulatory Focus en 2025-08-20 Industry and consumer groups call for improved review practices, transparency in PDUFA VIII https://www.raps.org/news-and-articles/news-articles/2025/8/report-japan-s-pmda-had-shortest-review-times-for Regulatory Focus en 2025-08-20 Report: Japans PMDA had shortest review times for new drugs, half of drugs submitted to US first https://www.raps.org/news-and-articles/news-articles/2025/8/fda-cites-firms-for-cgmp-violations,-unapproved-pr Regulatory Focus en 2025-08-19 FDA cites firms for CGMP violations, unapproved products, and device reporting issues https://www.raps.org/news-and-articles/news-articles/2025/8/latin-america-roundup-anmat-pharmacovigilance-offi Regulatory Focus en 2025-08-19 Latin America Roundup: ANMAT pharmacovigilance official fired amid fentanyl scandal https://www.raps.org/news-and-articles/news-articles/2025/8/radiopharmaceuticals-fda-draft-guidance-offers-tai Regulatory Focus en 2025-08-19 Radiopharmaceuticals: FDA draft guidance offers tailored approach for optimizing dose https://www.raps.org/news-and-articles/news-articles/2025/8/recon-ptc-gets-fda-crl-for-friedreich-s-ataxia-dru Regulatory Focus en 2025-08-19 Recon: PTC gets FDA CRL for Friedreichs ataxia drug Pediatrics group breaks with HHS to recommend COVID vaccines for young children https://www.raps.org/news-and-articles/news-articles/2025/8/cber-otp-clinical-hold-pilot-assessment-for-cellul Regulatory Focus en 2025-08-19 CBEROTP clinical hold pilot assessment for cellular and gene therapy INDs https://www.raps.org/news-and-articles/news-articles/2025/8/fda-proposes-guidance-on-using-overall-survival-en Regulatory Focus en 2025-08-18 FDA proposes guidance on using overall survival endpoints in cancer drug trials https://www.raps.org/news-and-articles/news-articles/2025/8/asia-pacific-roundup-singapore,-hong-kong-sign-coo Regulatory Focus en 2025-08-18 Asia-Pacific Roundup: Singapore, Hong Kong sign cooperative regulatory agreement for health products https://www.raps.org/news-and-articles/news-articles/2025/8/recon-novo-nordisk-to-sell-discounted-glp-1s-at-th Regulatory Focus en 2025-08-18 Recon: Novo Nordisk to sell discounted GLP-1s at the pharmacies FDAs absence from international standards meetings imperils US leadership https://www.raps.org/news-and-articles/news-articles/2025/8/study-disputes-claims-of-rampant-conflicts-of-inte Regulatory Focus en 2025-08-18 Study disputes claims of rampant conflicts of interest within ACIP and VRBAC https://www.raps.org/news-and-articles/news-articles/2025/8/yale-experts-urge-reforming-–-not-gutting-–-pdufa Regulatory Focus en 2025-08-18 Yale experts urge reforming not gutting PDUFA https://www.raps.org/news-and-articles/news-articles/2025/8/this-week-prasads-back-fda-considers-covid-authori Regulatory Focus en 2025-08-15 This Week: Prasads back, FDA considers COVID authorization, MAHA draft report leaked https://www.raps.org/news-and-articles/news-articles/2025/8/fda-seeks-feedback-on-ways-to-bring-manufacturing Regulatory Focus en 2025-08-15 FDA seeks feedback on ways to bring manufacturing back to the US https://www.raps.org/news-and-articles/news-articles/2025/8/president-trump-signs-executive-order-to-fill-the Regulatory Focus en 2025-08-14 President Trump signs executive order to fill the strategic stockpile https://www.raps.org/news-and-articles/news-articles/2025/8/recon-pharma-industry-nears-clarity-on-gdpr-applic Regulatory Focus en 2025-08-14 Recon: Pharma industry nears clarity on GDPR application for PV, trials Investors warier than ever of funding mRNA vax https://www.raps.org/news-and-articles/news-articles/2025/8/euro-roundup-mhra-seeks-feedback-on-in-house-manuf Regulatory Focus en 2025-08-14 Euro Roundup: MHRA seeks feedback on in-house manufacturing exemptions for medical devices https://www.raps.org/news-and-articles/news-articles/2025/8/industry-wants-more-transparency,-dedicated-progra Regulatory Focus en 2025-08-13 Industry wants more transparency, dedicated program for complex generics in GDUFA IV https://www.raps.org/news-and-articles/news-articles/2025/8/fda-warns-spectra-therapy-for-gmp-violations,-mark Regulatory Focus en 2025-08-12 FDA warns Spectra Therapy for GMP violations, marketing unapproved device https://www.raps.org/news-and-articles/news-articles/2025/8/who-proposes-updated-method-for-testing-liquid-dru Regulatory Focus en 2025-08-12 WHO proposes updated method for testing liquid drugs for DEGEG https://www.raps.org/news-and-articles/news-articles/2025/8/recon-fda-approves-insmed-s-chronic-lung-disease-d Regulatory Focus en 2025-08-12 Recon: FDA approves Insmeds chronic lung disease drug Sanofi halts supply of cholesterol drug to China due to supply constraints https://www.raps.org/news-and-articles/news-articles/2025/8/fda-s-drug-quality-report-notes-‘significant-uptic Regulatory Focus en 2025-08-11 FDAs drug quality report notes significant uptick in inspections since pandemic https://www.raps.org/news-and-articles/news-articles/2025/8/stakeholders-at-odds-over-fda-s-draft-guidance-on Regulatory Focus en 2025-08-11 Stakeholders at odds over FDAs draft guidance on hernia mesh labeling https://www.raps.org/news-and-articles/news-articles/2025/8/asia-pacific-roundup-china-and-malaysia-start-reci Regulatory Focus en 2025-08-11 Asia-Pacific Roundup: China and Malaysia start reciprocal medical device reliance pilot program https://www.raps.org/news-and-articles/news-articles/2025/8/recon-prasad-returns-fda-as-cber-chief;-fda-grants Regulatory Focus en 2025-08-11 Recon: Prasad returns FDA as CBER chief FDA grants priority review for GSKs gonorrhea antibiotic https://www.raps.org/news-and-articles/news-articles/2025/8/this-week-at-fda-precheck-manufacturing-program,-n Regulatory Focus en 2025-08-08 This Week at FDA: PreCheck manufacturing program, new FDA chief counsel, and more https://www.raps.org/news-and-articles/news-articles/2025/8/who,-un-report-uncovers-supply-chain-weaknesses-th Regulatory Focus en 2025-08-08 WHO, UN report uncovers supply chain weaknesses that contributed to patient deaths https://www.raps.org/news-and-articles/news-articles/2025/8/ich-releases-q3e-guideline-on-controlling-extracta Regulatory Focus en 2025-08-07 ICH releases Q3E guideline on controlling extractables and leachables in drugs https://www.raps.org/news-and-articles/news-articles/2025/8/european-commission-lack-of-alternatives-to-tio2-p Regulatory Focus en 2025-08-07 European Commission: Lack of alternatives to TiO2 precludes ban in drugs https://www.raps.org/news-and-articles/news-articles/2025/8/euro-roundup-uk-aims-to-speed-market-access-by-6-m Regulatory Focus en 2025-08-07 Euro Roundup: UK aims to speed market access by 6 months by coordinating MHRA, NICE reviews https://www.raps.org/news-and-articles/news-articles/2025/8/recon-lilly-s-weight-loss-pill-shows-disappointing Regulatory Focus en 2025-08-07 Recon: Lillys weight loss pill shows disappointing results FDA moves to boost US drug manufacturing https://www.raps.org/news-and-articles/news-articles/2025/8/ema-proposes-updating-guideline-for-alzheimer-s-di Regulatory Focus en 2025-08-06 EMA proposes updating guideline for Alzheimers disease treatments https://www.raps.org/news-and-articles/news-articles/2025/8/industry-asks-for-clarification,-consistency-in-fd Regulatory Focus en 2025-08-06 Industry asks for clarification, consistency in FDAs 510k transfer guidance https://www.raps.org/news-and-articles/news-articles/2025/8/an-overview-of-the-fda-s-start-pilot-program Regulatory Focus en 2025-08-06 An overview of the FDAs START pilot program https://www.raps.org/news-and-articles/news-articles/2025/8/fda-issues-warning-letters-for-cgmp-violations,-ma Regulatory Focus en 2025-08-05 FDA issues warning letters for CGMP violations, marketing devices for unintended uses https://www.raps.org/news-and-articles/news-articles/2025/8/latin-america-roundup-anmat-sanctions-more-domesti Regulatory Focus en 2025-08-05 Latin America Roundup: ANMAT sanctions more domestic drugmakers https://www.raps.org/news-and-articles/news-articles/2025/8/recon-fda-names-new-chief-counsel-trump-says-phar Regulatory Focus en 2025-08-05 Recon: FDA names new chief counsel Trump says pharma imports to face small tariff at first https://www.raps.org/news-and-articles/news-articles/2025/8/mdufa-vi-fda-eyes-growth-while-industry-seeks-refi Regulatory Focus en 2025-08-04 MDUFA VI: FDA eyes growth while industry seeks refinement https://www.raps.org/news-and-articles/news-articles/2025/8/pharma-groups-suggest-changes-to-fda-s-guidance-on Regulatory Focus en 2025-08-04 Pharma groups suggest changes to FDAs guidance on replacing color additives https://www.raps.org/news-and-articles/news-articles/2025/8/recon-pazdur-reportedly-intervened-in-replimune-de Regulatory Focus en 2025-08-04 Recon: Pazdur reportedly intervened in Replimune decision Eli Lilly to sell New Jersey facility https://www.raps.org/news-and-articles/news-articles/2025/8/asia-pacific-roundup-tga-identifies-pressing-need Regulatory Focus en 2025-08-04 Asia-Pacific Roundup: TGA identifies pressing need for guidance on adaptive and generative AI https://www.raps.org/news-and-articles/news-articles/2025/8/this-week-at-fda-prasads-exit-from-cber-7oh-schedu Regulatory Focus en 2025-08-01 This Week at FDA: Prasads exit from CBER, 7-OH scheduling, updated opioid labeling https://www.raps.org/news-and-articles/news-articles/2025/7/fda-warns-firms-for-cgmp,-qsr-violations;-online-r Regulatory Focus en 2025-07-31 FDA warns firms for CGMP, QSR violations online retailers cited for selling unapproved drugs https://www.raps.org/news-and-articles/news-articles/2025/7/recon-moderna-to-layoff-10-of-staff-trump-pressur Regulatory Focus en 2025-07-31 Recon: Moderna to layoff 10 of staff Trump pressures drugmakers to cut US prices https://www.raps.org/news-and-articles/news-articles/2025/7/euro-roundup-notified-bodies-propose-eu-level-medt Regulatory Focus en 2025-07-31 Euro Roundup: Notified bodies propose EU-level medtech coordination and support structure https://www.raps.org/news-and-articles/news-articles/2025/7/connected-obds-and-regulatory-implications-in-the Regulatory Focus en 2025-07-31 Connected OBDS and regulatory implications in the US https://www.raps.org/news-and-articles/news-articles/2025/7/investment-in-quality-management-can-reduce-defect Regulatory Focus en 2025-07-30 Investment in quality management can reduce defects and recalls, FDA says https://www.raps.org/news-and-articles/news-articles/2025/7/fda-unveils-fy-2026-user-fee-rates Regulatory Focus en 2025-07-30 FDA unveils FY 2026 user fee rates https://www.raps.org/news-and-articles/news-articles/2025/7/navigating-the-transition-implementing-the-new-eu Regulatory Focus en 2025-07-30 Navigating the transition: Implementing the new EU CTR in the pharmaceutical industry https://www.raps.org/news-and-articles/news-articles/2025/7/experts-offer-advice-on-avoiding-common-warning-le Regulatory Focus en 2025-07-29 Experts offer advice on avoiding common warning letter citations https://www.raps.org/news-and-articles/news-articles/2025/7/device-makers-seek-flexibility,-clarity-in-q-sub-e Regulatory Focus en 2025-07-29 Device makers seek flexibility, clarity in Q-sub electronic submission guidance https://www.raps.org/news-and-articles/news-articles/2025/6/experts-manufacturers-largely-met-may-dscsa-deadli Regulatory Focus en 2025-07-29 Manufacturers largely met May DSCSA deadline without major issues, experts say https://www.raps.org/news-and-articles/news-articles/2025/7/recon-sarepta-resumes-shipments-of-elevidys-for-am Regulatory Focus en 2025-07-29 Recon: Sarepta resumes shipments of Elevidys for ambulatory patients Merck to cut costs by 3B https://www.raps.org/news-and-articles/news-articles/2025/7/fda,-asco-propose-principles-for-proper-dosing-in Regulatory Focus en 2025-07-28 FDA, ASCO propose principles for proper dosing in cancer drug development https://www.raps.org/news-and-articles/news-articles/2025/7/7-year-fda-review-finds-improved-gcp-compliance Regulatory Focus en 2025-07-28 7-year FDA review finds improved GCP compliance https://www.raps.org/news-and-articles/news-articles/2025/7/asia-pacific-roundup-drap-publishes-guidance-on-tr Regulatory Focus en 2025-07-28 Asia-Pacific Roundup: DRAP publishes guidance on trials, biosimilarity studies of drugs made in Pakistan https://www.raps.org/news-and-articles/news-articles/2025/7/recon-gsk-pays-$500m-upfront-to-hengrui-for-rights Regulatory Focus en 2025-07-28 Recon: GSK pays 500M upfront to Hengrui for rights to several drugs PE firms offer 3B to buy Bavarian Nordic https://www.raps.org/news-and-articles/news-articles/2025/7/this-week-at-fda-expert-panels-draw-criticism,-hhs Regulatory Focus en 2025-07-25 This Week at FDA: Expert panels draw criticism, HHS seeks to define ultra-processed foods https://www.raps.org/news-and-articles/news-articles/2025/7/ema-proposes-reflection-paper-on-using-external-co Regulatory Focus en 2025-07-25 EMA proposes reflection paper on using external controls to generate evidence https://www.raps.org/news-and-articles/news-articles/2025/7/fda-white-paper-encourages-adoption-of-selective-s Regulatory Focus en 2025-07-25 FDA white paper encourages adoption of selective safety data collection https://www.raps.org/news-and-articles/news-articles/2025/7/ema-drug-repurposing-efforts-saw-limited-success-d Regulatory Focus en 2025-07-24 EMA: Drug repurposing efforts saw limited success during pilot https://www.raps.org/news-and-articles/news-articles/2025/7/questions-remain-as-fda-opens-submissions-for-new Regulatory Focus en 2025-07-24 Questions remain as FDA opens submissions for new priority voucher program https://www.raps.org/news-and-articles/news-articles/2025/7/euro-roundup-eu-committee-calls-for-cma-to-reflect Regulatory Focus en 2025-07-24 Euro Roundup: EU committee calls for CMA to reflect burden of green legislation https://www.raps.org/news-and-articles/news-articles/2025/7/recon-novartis-matchpoint-sign-$1b-deal-to-develo Regulatory Focus en 2025-07-24 Recon: Novartis, Matchpoint sign 1B deal to develop anti-inflammatory drugs FDA reinstated a quarter of jobs cut by DOGE, Makary says https://www.raps.org/news-and-articles/news-articles/2025/7/raps-honors-9-regulatory-professionals-and-one-org Regulatory Focus en 2025-07-24 RAPS honors 9 regulatory professionals and one organization with 2025 awards https://www.raps.org/news-and-articles/news-articles/2025/7/mhra-s-framework-point-of-care-personalized-medici Regulatory Focus en 2025-07-23 MHRAs framework point-of-care personalized medicine goes into effect https://www.raps.org/news-and-articles/news-articles/2025/7/cbo-nih-budget-cuts,-slower-fda-reviews-would-have Regulatory Focus en 2025-07-22 CBO: NIH budget cuts, slower FDA reviews would have significant impact on drug development https://www.raps.org/news-and-articles/news-articles/2025/7/fda-warns-glenmark-for-failure-to-investigate-diss Regulatory Focus en 2025-07-22 FDA warns Glenmark for failure to investigate dissolution failures https://www.raps.org/news-and-articles/news-articles/2025/7/mhra-to-move-forward-with-medical-device-reliance Regulatory Focus en 2025-07-22 MHRA to move forward with medical device reliance plans https://www.raps.org/news-and-articles/news-articles/2025/7/latin-america-roundup-mexico-formalizes-regulatory Regulatory Focus en 2025-07-22 Latin America Roundup: Mexico formalizes regulatory reliance strategy https://www.raps.org/news-and-articles/news-articles/2025/7/recon-fda-rejects-replimune-s-oncolytic-virus-drug Regulatory Focus en 2025-07-22 Recon: FDA rejects Replimunes oncolytic virus drug over study issues Sarepta to halt shipments of Duchenne gene therapy https://www.raps.org/news-and-articles/news-articles/2024/3/regulatory-affairs-leadership-training Regulatory Focus en 2025-07-22 What these 6 regulatory leaders learned at the RAPS Kellogg Executive Development Program https://www.raps.org/news-and-articles/news-articles/2025/7/fda-names-biotech-entrepreneur,-stanford-professor Regulatory Focus en 2025-07-21 FDA names biotech entrepreneur, Stanford professor as new CDER chief https://www.raps.org/news-and-articles/news-articles/2025/7/fda-panel-debates-label-change-on-ssri-use-during Regulatory Focus en 2025-07-21 FDA panel debates label change on SSRI use during pregnancy https://www.raps.org/news-and-articles/news-articles/2025/7/trump-gives-device-sterilizers-two-more-years-to-c Regulatory Focus en 2025-07-21 Trump gives device sterilizers two more years to comply with EtO limits https://www.raps.org/news-and-articles/news-articles/2025/7/recon-fda-panel-votes-against-otsuka-lundbeck-pts Regulatory Focus en 2025-07-21 Recon: FDA panel votes against Otsuka, Lundbeck PTSD drug Biogen announces 2B upgrades to NC facilities https://www.raps.org/news-and-articles/news-articles/2025/7/asia-pacific-roundup-india-s-cdsco-shares-guidance Regulatory Focus en 2025-07-21 Asia-Pacific Roundup: Indias CDSCO shares guidance on seeking clearance to export new drugs https://www.raps.org/news-and-articles/news-articles/2025/7/australia-regulatory-device-summit-2025-recap Regulatory Focus en 2025-07-21 340 Global Regulators, Health Authorities and Industry Partners Gather in Sydney for Australia Regulatory Device Summit 2025 https://www.raps.org/news-and-articles/news-articles/2025/7/this-week-at-fda-fda-revokes-food-standards,-says Regulatory Focus en 2025-07-18 This Week at FDA: FDA revokes food standards, says no to WHO pandemic regulation, and more https://www.raps.org/news-and-articles/news-articles/2025/7/fda-finalizes-guidance-for-efficient-biosimilars-m Regulatory Focus en 2025-07-18 FDA finalizes guidance for efficient biosimilars meetings, per BsUFA III https://www.raps.org/news-and-articles/news-articles/2025/7/panel-urges-fda-to-remove-boxed-warning-on-women-s Regulatory Focus en 2025-07-17 Panel urges FDA to remove boxed warning on womens hormone therapy https://www.raps.org/news-and-articles/news-articles/2025/7/euro-roundup-ema-identifies-need-to-adapt-framewor Regulatory Focus en 2025-07-17 Euro Roundup: EMA identifies need to adapt frameworks, processes to accommodate AI https://www.raps.org/news-and-articles/news-articles/2025/7/recon-bms-pfizer-to-sell-eliquis-direct-to-patien Regulatory Focus en 2025-07-17 Recon: BMS, Pfizer to sell Eliquis direct to patients at a discount Sarepta to layoff 500 staff as it adds boxed warning for DMD gene therapy https://www.raps.org/news-and-articles/news-articles/2025/7/fda-issues-guidance-on-developing-cancer-drugs-in Regulatory Focus en 2025-07-16 FDA issues guidance on developing cancer drugs in combination with other treatments https://www.raps.org/news-and-articles/news-articles/2025/7/uk-sets-plan-to-be-euro-life-sciences-leader-by-20 Regulatory Focus en 2025-07-16 UK sets plan to be Euro life sciences leader by 2030 https://www.raps.org/news-and-articles/news-articles/2025/7/challenges-and-best-practices-in-planning-and-exec Regulatory Focus en 2025-07-16 Challenges and best practices in planning and executing PMCF surveys https://www.raps.org/news-and-articles/news-articles/2025/7/mdcg-outlines-timeline-for-complying-with-new-udi Regulatory Focus en 2025-07-15 MDCG outlines timeline for complying with new UDI-DI for contact lenses and glasses https://www.raps.org/news-and-articles/news-articles/2025/7/fda-warns-wearable-tech-firm,-korean-drugmaker,-an Regulatory Focus en 2025-07-15 FDA warns wearable tech firm, Korean drugmaker, and sellers of Kratom-derived compound https://www.raps.org/news-and-articles/news-articles/2025/7/recon-fda-reviewers-flag-eye-risks-with-gsk-s-bloo Regulatory Focus en 2025-07-15 Recon: FDA reviewers flag eye risks with GSKs blood cancer therapy FDA ends import screening exemption for low-value goods https://www.raps.org/news-and-articles/news-articles/2025/7/study-most-nononcology-accelerated-approval-pivota Regulatory Focus en 2025-07-15 Study: Most nononcology accelerated approval pivotal trials use surrogate endpoints https://www.raps.org/news-and-articles/news-articles/2025/7/rif-separation-letters-go-out-to-hhs-employees-aft Regulatory Focus en 2025-07-14 RIF separation letters go out to HHS employees after Supreme Court order https://www.raps.org/news-and-articles/news-articles/2025/7/makary-suggests-lower-pdufa-fees-as-reauthorizatio Regulatory Focus en 2025-07-14 Makary suggests lower PDUFA fees as reauthorization process begins https://www.raps.org/news-and-articles/news-articles/2025/7/mhra-plans-to-align-with-eu-common-specifications Regulatory Focus en 2025-07-14 MHRA plans to align with EU common specifications for high-risk IVDs https://www.raps.org/news-and-articles/news-articles/2025/7/recon-zimmer-to-acquire-robotics-firm-monogram-for Regulatory Focus en 2025-07-14 Recon: Zimmer to acquire robotics firm Monogram for 177M WHO adds Gileads biannual HIV shot to PrEP guidelines https://www.raps.org/news-and-articles/news-articles/2025/7/asia-pacific-roundup-korean-pharmacopoeia-selected Regulatory Focus en 2025-07-14 Asia-Pacific Roundup: Korean Pharmacopoeia selected to participate in Pharmacopeial Discussion Group https://www.raps.org/news-and-articles/news-articles/2025/7/this-week-at-fda-makary-celebrates-first-100-days Regulatory Focus en 2025-07-11 This Week at FDA: Makary celebrates first 100 days, Senate committee passes FDA budget bill, and more https://www.raps.org/news-and-articles/news-articles/2025/7/makary-lauds-user-fees-as-fda-begins-gdufa-iv-reau Regulatory Focus en 2025-07-11 Makary lauds user fees as FDA begins GDUFA IV reauthorization process https://www.raps.org/news-and-articles/news-articles/2025/7/sources-fda-won-t-pay-bonuses-to-rifed,-similar-em Regulatory Focus en 2025-07-10 Sources: FDA wont pay bonuses to RIFed, similar employees https://www.raps.org/news-and-articles/news-articles/2025/7/fda-publishes-200-complete-response-letters-in-tra Regulatory Focus en 2025-07-10 FDA publishes 200 complete response letters in transparency effort https://www.raps.org/news-and-articles/news-articles/2025/7/recon-fda-approves-modernas-covid-shot-for-at-risk Regulatory Focus en 2025-07-10 Recon: FDA approves Modernas COVID shot for at risk children Merck to buy Verona for 10B https://www.raps.org/news-and-articles/news-articles/2025/7/euro-roundup-ema-survey-shows-smes-want-simplifica Regulatory Focus en 2025-07-10 Euro Roundup: EMA survey shows SMEs want simplification, streamlining to ease regulatory burdens https://www.raps.org/news-and-articles/news-articles/2025/7/eu-expert-group-established-for-pediatric-and-rare Regulatory Focus en 2025-07-09 EU expert group established for pediatric and rare disease devices https://www.raps.org/news-and-articles/news-articles/2025/7/european-commission-proposes-on-updated-gmp-guidel Regulatory Focus en 2025-07-09 European Commission proposes on updated GMP guidelines for AI https://www.raps.org/news-and-articles/news-articles/2025/7/raps-announces-board-of-directors-for-2026 Regulatory Focus en 2025-07-09 RAPS announces Board of Directors for 2026 https://www.raps.org/news-and-articles/news-articles/2025/7/from-data-to-decisions-real-world-evidence-for-med Regulatory Focus en 2025-07-09 From data to decisions: Real-world evidence for medical devices in the US and the EU https://www.raps.org/news-and-articles/news-articles/2025/7/fda-nih-officials-look-to-curb-animal-testing-in Regulatory Focus en 2025-07-08 FDA, NIH officials look to curb animal testing in drug development https://www.raps.org/news-and-articles/news-articles/2025/7/study-fda-more-likely-to-approve-drugs-for-broader Regulatory Focus en 2025-07-08 Study: FDA more likely to approve drugs for broader populations than EMA, Swissmedic https://www.raps.org/news-and-articles/news-articles/2025/7/recon-trump-threatens-200-tariffs-on-drugs-novo-se Regulatory Focus en 2025-07-08 Recon: Trump threatens 200 tariffs on drugs Novo seeks EU authorization for higher Wegovy dose https://www.raps.org/news-and-articles/news-articles/2025/7/unwanted-immunogenicity-testing-–-challenges-linge Regulatory Focus en 2025-07-08 Unwanted immunogenicity testing Challenges linger despite guidance and improved requirements https://www.raps.org/news-and-articles/news-articles/2025/7/raps-topra-conferences-london-2025 Regulatory Focus en 2025-07-08 RAPS and TOPRA Open Registration for Two London-Based Conferences this November https://www.raps.org/news-and-articles/news-articles/2025/7/parenteral-drugs-fda-replaces-guidance-on-aluminum Regulatory Focus en 2025-07-07 Parenteral drugs: FDA replaces guidance on aluminum content limits https://www.raps.org/news-and-articles/news-articles/2025/7/fda-proposes-clinical-trial,-endpoint-consideratio Regulatory Focus en 2025-07-07 FDA proposes clinical trial, endpoint considerations in MDS drug development guidance https://www.raps.org/news-and-articles/news-articles/2025/7/recon-medical-societies-sue-hhs-over-vaccine-polic Regulatory Focus en 2025-07-07 Recon: Medical societies sue HHS over vaccine policy FDA approves KalVistas swelling disorder drug https://www.raps.org/news-and-articles/news-articles/2025/7/asia-pacific-roundup-tga-outlines-new-measures-to Regulatory Focus en 2025-07-07 Asia-Pacific Roundup: TGA outlines new measures to ID, manage device-related safety concerns https://www.raps.org/news-and-articles/news-articles/2025/7/euro-roundup-swissmedic-pilots-fast-track-procedur Regulatory Focus en 2025-07-03 Euro Roundup: Swissmedic pilots fast-track procedure to accelerate clinical trial authorizations https://www.raps.org/news-and-articles/news-articles/2025/7/recon-fda-approves-regeneron-s-blood-cancer-drug; Regulatory Focus en 2025-07-03 Recon: FDA approves Regenerons blood cancer drug House passes Trump spending bill https://www.raps.org/news-and-articles/news-articles/2025/7/ema-reports-uptick-in-rwd-studies-growth-in-darwi Regulatory Focus en 2025-07-02 EMA reports uptick in RWD studies, growth in DARWIN network https://www.raps.org/news-and-articles/news-articles/2025/7/meet-the-2025-raps-fellows Regulatory Focus en 2025-07-02 Meet the 2025 RAPS Fellows https://www.raps.org/news-and-articles/news-articles/2025/7/fda-warning-letters-cite-sti-testing-failures,-fac Regulatory Focus en 2025-07-01 FDA warning letters cite STI testing failures, facilities with animal feces, and a researcher who overdosed autistic children https://www.raps.org/news-and-articles/news-articles/2025/7/recon-supreme-court-won-t-review-oklahoma-pbm-law; Regulatory Focus en 2025-07-01 Recon: Supreme Court wont review Oklahoma PBM law Senate passes megabill after marathon voting session https://www.raps.org/news-and-articles/news-articles/2025/7/new-label-requirement-for-adhd-stimulants-warns-of Regulatory Focus en 2025-07-01 New label requirement for ADHD stimulants warns of weight-loss risk in young children https://www.raps.org/news-and-articles/news-articles/2025/7/latin-america-roundup-brazil-law-restores-five-yea Regulatory Focus en 2025-07-01 Latin America Roundup: Brazil law restores five-year limit on free study drugs https://www.raps.org/news-and-articles/news-articles/2025/6/fda-eliminates-rems-for-approved-car-t-therapies Regulatory Focus en 2025-06-30 FDA eliminates REMS for approved CAR-T therapies https://www.raps.org/news-and-articles/news-articles/2025/6/study-some-breakthrough-designated-devices-have-li Regulatory Focus en 2025-06-30 Study: Some breakthrough-designated devices have limited evidence supporting safety, effectiveness https://www.raps.org/news-and-articles/news-articles/2025/6/european-commission-expands-use-of-eifus Regulatory Focus en 2025-06-30 European Commission expands use of eIFUs https://www.raps.org/news-and-articles/news-articles/2025/6/recon-republicans-revise-healthcare-measures-in-ta Regulatory Focus en 2025-06-30 Recon: Republicans revise healthcare measures in tax bill EU countries rally behind pathway for IVDdrug trials https://www.raps.org/news-and-articles/news-articles/2025/6/fda-replaces-cybersecurity-guidance-for-medical-de Regulatory Focus en 2025-06-30 FDA replaces cybersecurity guidance for medical devices, again https://www.raps.org/news-and-articles/news-articles/2025/6/asia-pacific-roundup-hong-kong-targets-2026-launch Regulatory Focus en 2025-06-30 Asia Pacific Roundup: Hong Kong targets 2026 launch for Centre for Medical Products Regulation https://www.raps.org/news-and-articles/news-articles/2025/6/this-week-at-fda-makary-and-a-crl-for-kalvista-mor Regulatory Focus en 2025-06-27 This Week at FDA: Makary and a CRL for KalVista, more FDA staff leaving, advisory panels slowed by staff cuts https://www.raps.org/news-and-articles/news-articles/2025/6/ich-releases-e20-guideline-to-assist-sponsors-in-d Regulatory Focus en 2025-06-27 ICH releases E20 guideline to assist sponsors in designing adaptive clinical trials https://www.raps.org/news-and-articles/news-articles/2025/6/fda-draft-guidance-outlines-udi-requirements-for-c Regulatory Focus en 2025-06-27 FDA draft guidance outlines UDI requirements for combination products https://www.raps.org/news-and-articles/news-articles/2025/6/recon-cdc-panel-recommends-infant-rsv-therapy-rfk Regulatory Focus en 2025-06-26 Recon: CDC panel recommends infant RSV therapy RFK says US will stop funding Gavi https://www.raps.org/news-and-articles/news-articles/2025/6/euro-roundup-mhra-publishes-guidance-on-clinical-t Regulatory Focus en 2025-06-26 Euro Roundup: MHRA publishes guidance on clinical trial processes under incoming UK regulations https://www.raps.org/news-and-articles/news-articles/2025/6/marks-decries-lack-of-transparency-in-fdas-revampe Regulatory Focus en 2025-06-25 Marks decries lack of transparency in FDAs revamped COVID vaccine policy https://www.raps.org/news-and-articles/news-articles/2025/6/fda-warns-sterling-distributors-for-multiple-dscsa Regulatory Focus en 2025-06-25 FDA warns Sterling Distributors for multiple DSCSA violations tied to investigating suspect products https://www.raps.org/news-and-articles/news-articles/2025/6/fda-finalizes-early-lyme-disease-drug-development Regulatory Focus en 2025-06-25 FDA finalizes early Lyme disease drug development guidance https://www.raps.org/news-and-articles/news-articles/2025/6/study-delaying-authorized-generics-is-on-the-decli Regulatory Focus en 2025-06-25 Study: Delaying authorized generics is on the decline https://www.raps.org/news-and-articles/news-articles/2025/6/jonathan-amaya-hodges-interview Regulatory Focus en 2025-06-25 Whats more important than knowing the regulations Getting to deliver high-quality products https://www.raps.org/news-and-articles/news-articles/2025/6/fda-will-permit-some-leeway-in-nitrosamine-testing Regulatory Focus en 2025-06-24 FDA extends deadline for nitrosamine testing submissions https://www.raps.org/news-and-articles/news-articles/2025/6/mdcg-guidance-clarifies-requirements-for-ai-produc Regulatory Focus en 2025-06-24 MDCG guidance clarifies requirements for AI products under AI Act, MDR, and IVDR https://www.raps.org/news-and-articles/news-articles/2025/6/fda-s-ldt-oversight-faces-an-uncertain-future-exp Regulatory Focus en 2025-06-24 FDAs LDT oversight faces an uncertain future, experts say https://www.raps.org/news-and-articles/news-articles/2025/6/recon-makary-reportedly-sought-crl-for-kalvista-dr Regulatory Focus en 2025-06-24 Recon: Makary reportedly sought CRL for KalVista drug Novo launches Wegovy in India https://www.raps.org/news-and-articles/news-articles/2025/6/fda-finalizes-guidance-on-requesting-post-warning Regulatory Focus en 2025-06-23 FDA finalizes guidance on requesting post-warning letter meetings https://www.raps.org/news-and-articles/news-articles/2025/6/fda,-nih-create-common-vocabulary-for-real-world-e Regulatory Focus en 2025-06-23 FDA, NIH create common vocabulary for real-world evidence https://www.raps.org/news-and-articles/news-articles/2025/6/recon-lilly-s-bimagrumab-plus-novo-s-wegovy-prove Regulatory Focus en 2025-06-23 Recon: Lillys bimagrumab plus Novos Wegovy prove potent for weight management MHRA adds second AI airlock https://www.raps.org/news-and-articles/news-articles/2025/6/corrigan-curay-announces-retirement-from-cder Regulatory Focus en 2025-06-23 Corrigan-Curay announces retirement from CDER https://www.raps.org/news-and-articles/news-articles/2025/6/asia-pacific-roundup-medsafe-considers-potency-inf Regulatory Focus en 2025-06-23 Asia-Pacific Roundup: Medsafe considers potency information to corticosteroid labels https://www.raps.org/news-and-articles/news-articles/2025/6/fda-says-elsa-can-t-hallucinate,-unlikely-to-ever Regulatory Focus en 2025-06-20 FDA: If used for document libraries, Elsa cannot hallucinate unlikely to be connected to the Internet https://www.raps.org/news-and-articles/news-articles/2025/6/this-week-at-fda-fda-announces-new-drug-voucher-pr Regulatory Focus en 2025-06-20 This Week at FDA: FDA announces new drug voucher program, Prasad gets another role, new CDER director might be named soon https://www.raps.org/news-and-articles/news-articles/2025/6/euro-roundup-mdcg-answers-questions-on-running-dia Regulatory Focus en 2025-06-19 Euro Roundup: MDCG answers questions on running diagnostic performance studies under IVDR https://www.raps.org/news-and-articles/news-articles/2025/6/recon-fda-approves-gilead-s-twice-yearly-hiv-shot Regulatory Focus en 2025-06-19 Recon: FDA approves Gileads twice-yearly HIV shot Two top FDA cell and gene therapy leaders pushed out https://www.raps.org/news-and-articles/news-articles/2025/6/makary-names-prasad-as-fda-s-chief-medical-officer Regulatory Focus en 2025-06-18 Makary names Prasad as FDAs chief medical and scientific officer https://www.raps.org/news-and-articles/news-articles/2025/6/fda-announces-new-voucher-program-for-drugs-tied-t Regulatory Focus en 2025-06-17 FDA announces new voucher program for drugs tied to national priorities https://www.raps.org/news-and-articles/news-articles/2025/6/mhra-leaders-tout-pragmatic-approach-to-regulation Regulatory Focus en 2025-06-17 MHRA leaders tout pragmatic approach to regulation post-Brexit https://www.raps.org/news-and-articles/news-articles/2025/6/latin-america-roundup-argentina-medicines-agency-t Regulatory Focus en 2025-06-17 Latin America Roundup: Argentina medicines agency to undergo systematic review https://www.raps.org/news-and-articles/news-articles/2025/6/recon-lilly-to-acquire-verve-in-potential-$1-3b-de Regulatory Focus en 2025-06-17 Recon: Lilly to acquire Verve in potential 13B deal RFK Jr eyes crackdown on drug ads https://www.raps.org/news-and-articles/news-articles/2025/6/makary-says-he-wants-nimbler-fda,-calls-for-new-dr Regulatory Focus en 2025-06-16 Makary says he wants nimbler FDA, calls for new drug pathways and pilots https://www.raps.org/news-and-articles/news-articles/2025/6/fda-finalizes-guidance-on-pre-submission-facility Regulatory Focus en 2025-06-16 FDA finalizes guidance on pre-submission facility correspondence for priority generic submissions https://www.raps.org/news-and-articles/news-articles/2025/6/asia-pacific-roundup-medsafe-seeks-feedback-on-sho Regulatory Focus en 2025-06-16 Asia-Pacific Roundup: Medsafe seeks feedback on showing medicine bioequivalence in New Zealand https://www.raps.org/news-and-articles/news-articles/2025/6/recon-lilly-to-sell-highest-doses-of-zepbound-on-i Regulatory Focus en 2025-06-16 Recon: Lilly to sell highest doses of Zepbound on its website Supernus to acquire Sage for 795M https://www.raps.org/news-and-articles/news-articles/2025/6/this-week-at-fda-kennedy-revamps-acip,-fda-seeks-c Regulatory Focus en 2025-06-13 This Week at FDA: Kennedy revamps ACIP, FDA seeks consumer advisors, MDUFA meeting scheduled https://www.raps.org/news-and-articles/news-articles/2025/6/study-notes-disparities-in-new-drugs-approved-in-t Regulatory Focus en 2025-06-13 Study notes disparities in new drugs approved in the US and Japan https://www.raps.org/news-and-articles/news-articles/2025/6/industry-tells-congress-incentives-needed-to-boost Regulatory Focus en 2025-06-12 Industry tells Congress incentives needed to boost domestic drug manufacturing https://www.raps.org/news-and-articles/news-articles/2025/6/makary-fda-to-look-into-further-consolidating-oper Regulatory Focus en 2025-06-12 Makary: FDA to look into further consolidating operations https://www.raps.org/news-and-articles/news-articles/2025/6/euro-roundup-efpia-pushes-eu-to-simplify-speed-up Regulatory Focus en 2025-06-12 Euro Roundup: EFPIA pushes EU to simplify, speed up clinical trial framework under Biotech Act https://www.raps.org/news-and-articles/news-articles/2025/6/recon-biontech-to-acquire-curevac-for-1-25b-fda Regulatory Focus en 2025-06-12 Recon: BioNTech to acquire CureVac for 125B FDA approves Urogens bladder cancer therapy https://www.raps.org/news-and-articles/news-articles/2025/6/fda-warns-sprout-over-addyi-instagram-post,-clinic Regulatory Focus en 2025-06-11 FDA warns Sprout over Addyi Instagram post, clinical trial sponsor for lacking an IND https://www.raps.org/news-and-articles/news-articles/2025/6/mhra-releases-spate-of-new-guidelines-on-decentral Regulatory Focus en 2025-06-10 MHRA releases spate of new guidelines on decentralized manufacturing https://www.raps.org/news-and-articles/news-articles/2025/6/ema-record-number-of-drugs-recommended-in-2024 Regulatory Focus en 2025-06-10 EMA: Record number of drugs recommended in 2024 https://www.raps.org/news-and-articles/news-articles/2025/6/recon-fda-approves-merck-s-rsv-antibody-for-infant Regulatory Focus en 2025-06-10 Recon: FDA approves Mercks RSV antibody for infants Gileads HIV combo studies placed on hold https://www.raps.org/news-and-articles/news-articles/2025/6/makary-prasad-lay-out-priorities-for-fda-reduced-t Regulatory Focus en 2025-06-10 Makary, Prasad lay out priorities for FDA: Reduced timelines, more AI, faster competition https://www.raps.org/news-and-articles/news-articles/2025/6/stakeholders-urge-fda-to-update-cgt-regulations-to Regulatory Focus en 2025-06-09 Stakeholders urge FDA to update CGT regulations to ease path to market for promising therapies https://www.raps.org/news-and-articles/news-articles/2025/6/fda-issues-guidance-on-transferring-510(k)-ownersh Regulatory Focus en 2025-06-09 FDA issues guidance on transferring 510k ownership https://www.raps.org/news-and-articles/news-articles/2025/6/asia-pacific-roundup-tga-takes-philips-to-court-a Regulatory Focus en 2025-06-09 Asia-Pacific Roundup: TGA takes Philips to court, alleging company unlawfully supplied devices in Australia https://www.raps.org/news-and-articles/news-articles/2025/6/recon-uk-halts-valneva-s-chikungunya-vaccine-cdc Regulatory Focus en 2025-06-09 Recon: UK halts Valnevas chikungunya vaccine CDC terminates all vaccine advisory committee members https://www.raps.org/news-and-articles/news-articles/2025/6/this-week-health-officials-want-to-cut-red-tape-fo Regulatory Focus en 2025-06-06 This Week: Health officials want to cut red tape for CGTs, FDAs budget advances, and more https://www.raps.org/news-and-articles/news-articles/2025/6/fda-s-recent-warning-letters-target-bimo-violation Regulatory Focus en 2025-06-06 FDAs warning letters cite firms over inadequate testing, BIMO violations https://www.raps.org/news-and-articles/news-articles/2025/6/rf-quarterly,-march-2025-regulatory-writing Regulatory Focus en 2025-06-06 RF Quarterly, June 2025: Regulatory writing https://www.raps.org/news-and-articles/news-articles/2025/6/regulatory-writing-a-clinical-overview-case-study Regulatory Focus en 2025-06-06 Regulatory writing: A clinical overview case study and points for consideration https://www.raps.org/news-and-articles/news-articles/2025/6/the-digital-ind-nda-bla-generative-ai-for-creating Regulatory Focus en 2025-06-06 The digital INDNDABLA: Generative AI for creating regulatory documents https://www.raps.org/news-and-articles/news-articles/2025/6/using-infographics-to-streamline-regulatory-docume Regulatory Focus en 2025-06-06 Using infographics to streamline regulatory document development https://www.raps.org/news-and-articles/news-articles/2025/6/writing-for-a-regulatory-audience Regulatory Focus en 2025-06-06 Writing for a regulatory audience https://www.raps.org/news-and-articles/news-articles/2025/6/fda-drafts-guidance,-orders-on-minor-changes-to-ot Regulatory Focus en 2025-06-06 FDA drafts guidance, orders on minor changes to OTC drugs and packaging https://www.raps.org/news-and-articles/news-articles/2025/6/eu-council-adopts-compromise-position-on-pharma-re Regulatory Focus en 2025-06-05 EU Council adopts compromise position on pharma reforms https://www.raps.org/news-and-articles/news-articles/2025/6/euro-roundup-ema-floats-change-in-paradigm-for-pr Regulatory Focus en 2025-06-05 Euro Roundup: EMA floats change in paradigm for pregnant and breastfeeding patients in clinical trials https://www.raps.org/news-and-articles/news-articles/2025/6/recon-patent-office-sides-with-merck-in-fight-over Regulatory Focus en 2025-06-05 Recon: Patent office sides with Merck in fight over injectable Keytruda Sarepta picks up platform technology designation for gene therapy vector https://www.raps.org/news-and-articles/news-articles/2025/6/latin-america-roundup-argentina-authorities-recall Regulatory Focus en 2025-06-04 Latin America Roundup: Argentina authorities recall fentanyl lots after dozens die https://www.raps.org/news-and-articles/news-articles/2025/6/fda-s-elsa-ai-tool-gets-mixed-response-from-some-s Regulatory Focus en 2025-06-04 FDAs Elsa AI tool gets mixed response from some staff https://www.raps.org/news-and-articles/news-articles/2025/6/fda-should-establish-a-public-database-of-device-l Regulatory Focus en 2025-06-03 FDA should establish a public database of device labels, experts say https://www.raps.org/news-and-articles/news-articles/2025/6/makary-criticizes-past-federal-covid-vaccine-moves Regulatory Focus en 2025-06-03 Makary criticizes past federal COVID vaccine moves, calls ACIP a kangaroo court https://www.raps.org/news-and-articles/news-articles/2025/6/asia-pacific-roundup-cdsco-advises-drugmakers-on-h Regulatory Focus en 2025-06-03 Asia-Pacific Roundup: CDSCO advises drugmakers on how to dispose of expired or unused medicines https://www.raps.org/news-and-articles/news-articles/2025/6/recon-wegovy-use-up-50-among-us-teens;-hims-to-acq Regulatory Focus en 2025-06-03 Recon: Wegovy use up 50 among US teens Hims to acquire UK-based telehealth firm Zava https://www.raps.org/news-and-articles/news-articles/2025/6/fda-launches-agency-wide-ai-tool-‘elsa-ahead-of-sc Regulatory Focus en 2025-06-02 FDA launches agency-wide AI tool Elsa ahead of schedule https://www.raps.org/news-and-articles/news-articles/2025/6/fda-majority-of-applicants-complied-with-postmarke Regulatory Focus en 2025-06-02 FDA: Majority of applicants complied with postmarketing requirements, commitments https://www.raps.org/news-and-articles/news-articles/2025/6/recon-sanofi-to-acquire-blueprint-in-$9b-deal-fda Regulatory Focus en 2025-06-02 Recon: Sanofi to acquire Blueprint in 9B deal FDA approves Modernas next-gen COVID vaccine for older adults https://www.raps.org/news-and-articles/news-articles/2025/5/this-week-cdc-partly-walks-back-rfk-s-covid-vaccin Regulatory Focus en 2025-05-30 This Week: CDC partly walks back RFKs COVID vaccine changes, fake citations found in MAHA report, and more https://www.raps.org/news-and-articles/news-articles/2025/5/fda-proposes-downgrading-drug-color-additive-chang Regulatory Focus en 2025-05-30 FDA proposes downgrading drug color additive changes to CBE-30 https://www.raps.org/news-and-articles/news-articles/2025/5/fda-final-guidance-adds-more-details-to-q-sub-prog Regulatory Focus en 2025-05-30 FDA final guidance adds more details to Q-Sub program https://www.raps.org/news-and-articles/news-articles/2025/5/repurposing-generic-drugs-experts-envision-new-reg Regulatory Focus en 2025-05-30 Repurposing generic drugs: Experts envision new regulatory pathway https://www.raps.org/news-and-articles/news-articles/2025/5/industry-wants-clarity-on-decentralized-trials-and Regulatory Focus en 2025-05-29 Industry wants clarity on decentralized trials and informed consent in ICH GCP annex https://www.raps.org/news-and-articles/news-articles/2025/5/recon-us-cuts-$700m-in-funding-for-moderna-bird-fl Regulatory Focus en 2025-05-29 Recon: US cuts 700M in funding for Moderna bird flu vaccine FDA approves Alcons dry eye drug https://www.raps.org/news-and-articles/news-articles/2025/5/euro-roundup-ec-seeks-feedback-on-medtech-joint-cl Regulatory Focus en 2025-05-29 Euro Roundup: EC seeks feedback on medtech joint clinical assessments https://www.raps.org/news-and-articles/news-articles/2025/5/ich-releases-guidelines-on-developing-medicines-fo Regulatory Focus en 2025-05-28 ICH releases guidelines on developing medicines for pregnant population and quality information in CTD https://www.raps.org/news-and-articles/news-articles/2025/5/fda-hands-drugmaker,-diagnostics-firm-warning-lett Regulatory Focus en 2025-05-28 FDA hands drugmaker, diagnostics firm warning letters for GMP violations https://www.raps.org/news-and-articles/news-articles/2025/5/euro-convergence-expert-says-the-future-needs-bion Regulatory Focus en 2025-05-27 Euro Convergence: The future calls for bionic regulatory professionals https://www.raps.org/news-and-articles/news-articles/2025/5/fda-warns-four-device-makers-over-lax-processes Regulatory Focus en 2025-05-27 FDA warns four device makers over lax processes https://www.raps.org/news-and-articles/news-articles/2025/5/recon-cdc-pulls-covid-vaccine-recommendation-for-h Regulatory Focus en 2025-05-27 Recon: CDC pulls COVID vaccine recommendation for healthy children, pregnant women Eli Lilly to purchase SiteOne in deal valued up to 1B https://www.raps.org/news-and-articles/news-articles/2025/5/asia-pacific-roundup-singapores-hsa-seeks-feedback Regulatory Focus en 2025-05-27 Asia-Pacific Roundup: Singapores HSA seeks feedback on exempting more AI software devices from requirements https://www.raps.org/news-and-articles/news-articles/2025/5/regulatory-affairs-certification-rac-rcc-spring-25 Regulatory Focus en 2025-05-27 These professionals earned their RAC or RCC credentials in spring 2025 https://www.raps.org/news-and-articles/news-articles/2025/5/this-week-at-fda-rfk-s-maha-report,-vrbpac-recomme Regulatory Focus en 2025-05-23 This Week at FDA: RFKs MAHA report, VRBPAC recommends COVID-19 boosters target newer JN1 strains https://www.raps.org/news-and-articles/news-articles/2025/5/euro-convergence-listen-to-questions,-concerns-dur Regulatory Focus en 2025-05-23 Euro Convergence: Listen to questions, concerns during structured dialogues with NBs, expert says https://www.raps.org/news-and-articles/news-articles/2025/5/fda-warning-letters-flag-gmp-violations,-false-adv Regulatory Focus en 2025-05-23 FDA warning letters flag GMP violations, false advertising of drugs https://www.raps.org/news-and-articles/news-articles/2025/5/fda-proposes-fy-2026-budget;-makary-offers-details Regulatory Focus en 2025-05-22 FDA proposes FY 2026 budget Makary offers details on staff attrition https://www.raps.org/news-and-articles/news-articles/2025/5/euro-roundup-mhra-seeks-feedback-on-using-external Regulatory Focus en 2025-05-22 Euro Roundup: MHRA seeks feedback on using external control arms based on RWD https://www.raps.org/news-and-articles/news-articles/2025/5/recon-maha-report-blames-diet-prescription-drugs Regulatory Focus en 2025-05-22 Recon: MAHA report blames diet, prescription drugs as causes of chronic illness FDA adcomm votes against Pfizers prostate cancer combo https://www.raps.org/news-and-articles/news-articles/2025/5/euro-convergence-experts-emphasize-careful-plannin Regulatory Focus en 2025-05-21 Euro Convergence: Experts emphasize careful planning for market launch strategy https://www.raps.org/news-and-articles/news-articles/2025/5/ich-announces-new-topics,-draft-guidelines-for-con Regulatory Focus en 2025-05-21 ICH announces new topics, draft guidelines for consultation https://www.raps.org/news-and-articles/news-articles/2025/5/regulatory-affairs-mentoring-angelina-lisandrelli Regulatory Focus en 2025-05-21 In regulatory affairs, mentorship is about hope https://www.raps.org/news-and-articles/news-articles/2025/5/experts-offer-advice-on-preparing-pccps Regulatory Focus en 2025-05-20 Experts offer advice on preparing PCCPs https://www.raps.org/news-and-articles/news-articles/2025/5/fda-unveils-new-covid-19-framework-restricting-sho Regulatory Focus en 2025-05-20 FDA unveils new COVID-19 framework, restricting shots to elderly and high-risk people https://www.raps.org/news-and-articles/news-articles/2025/5/recon-who-adopts-pandemic-treaty-us-unveils-most-f Regulatory Focus en 2025-05-20 Recon: WHO adopts pandemic treaty, US unveils most-favored-nation pricing targets https://www.raps.org/news-and-articles/news-articles/2025/5/latin-america-roundup-push-for-uraguay-medicines-a Regulatory Focus en 2025-05-20 Latin America Roundup: Push for Uraguay medicines agency faces opposition https://www.raps.org/news-and-articles/news-articles/2025/5/fda-deputy-commissioner-hints-at-potential-changes Regulatory Focus en 2025-05-19 FDA deputy commissioner hints at potential changes to PDUFA https://www.raps.org/news-and-articles/news-articles/2025/5/asia-pacific-roundup-tga-seeks-feedback-on-interna Regulatory Focus en 2025-05-19 Asia-Pacific Roundup: TGA seeks feedback on international clinical trial, pharmacovigilance guidelines https://www.raps.org/news-and-articles/news-articles/2025/5/recon-novavax-nabs-narrowed-fda-approval-for-covid Regulatory Focus en 2025-05-19 Recon: Novavax nabs narrowed FDA approval for COVID-19 vaccine FDA clears first blood test for Alzheimers https://www.raps.org/news-and-articles/news-articles/2025/5/safeguarding-proprietary-data-the-regulatory-toolb Regulatory Focus en 2025-05-16 Safeguarding proprietary data: The regulatory toolboxs fine print https://www.raps.org/news-and-articles/news-articles/2025/5/trends-in-opdp-research-and-recent-enforcement-act Regulatory Focus en 2025-05-16 Trends in OPDP research and recent enforcement actions https://www.raps.org/news-and-articles/news-articles/2025/5/this-week-at-fda-kennedy-defends-hhs-cuts-drug-pr Regulatory Focus en 2025-05-16 This week at FDA: Kennedy defends HHS cuts, drug pricing EO, and more https://www.raps.org/news-and-articles/news-articles/2025/5/euro-convergence-officials-discuss-ai-in-regulator Regulatory Focus en 2025-05-16 Euro Convergence: Officials discuss AI in regulatory, hope pharma legislation will streamline combo product review https://www.raps.org/news-and-articles/news-articles/2025/5/fda-commissioner-makary-talks-priorities,-says-rec Regulatory Focus en 2025-05-15 Makary talks FDA priorities, says recent cuts addressed redundancies https://www.raps.org/news-and-articles/news-articles/2025/5/euro-convergence-expert-offers-advice-on-making-th Regulatory Focus en 2025-05-15 Euro Convergence: Expert offers advice on making the best of EUDAMED https://www.raps.org/news-and-articles/news-articles/2025/5/euro-roundup-efpia-calls-on-eu-to-support-ema-ai-s Regulatory Focus en 2025-05-15 Euro Roundup: EFPIA calls on EU to support EMA AI spending, upskilling in 2028-2034 funding plan https://www.raps.org/news-and-articles/news-articles/2025/5/recon-kennedy-defends-hhs-cuts-in-contentious-hear Regulatory Focus en 2025-05-15 Recon: Kennedy defends HHS cuts in contentious hearing FDA approves Amneals self-administered migraine therapy https://www.raps.org/news-and-articles/news-articles/2025/5/euro-convergence-experts-discuss-ai-act-s-future-a Regulatory Focus en 2025-05-14 Euro Convergence: Experts discuss AI Acts future and impact on medtech https://www.raps.org/news-and-articles/news-articles/2025/5/fda-warns-foreign-drugmakers-over-mold,-filthy-fac Regulatory Focus en 2025-05-14 FDA warns foreign drugmakers over mold, filthy facilities, and other GMP issues https://www.raps.org/news-and-articles/news-articles/2025/5/10-to-1-hhs-solicits-comments-on-regulations-to-el Regulatory Focus en 2025-05-13 10-to-1: HHS solicits comments on regulations to eliminate under Trump EO https://www.raps.org/news-and-articles/news-articles/2025/5/euro-convergence-experts-support-mdr-ivdr-tweaks Regulatory Focus en 2025-05-13 Euro Convergence: Experts support MDR, IVDR tweaks to ensure competitiveness https://www.raps.org/news-and-articles/news-articles/2025/5/recon-fda-looks-to-remove-ingestible-fluoride-prod Regulatory Focus en 2025-05-13 Recon: FDA looks to remove ingestible fluoride products from the market ITeos and GSK halt developing lung cancer therapy https://www.raps.org/news-and-articles/news-articles/2025/5/international-group-proposes-best-practices-for-ai Regulatory Focus en 2025-05-12 International group proposes best practices for AI in pharmacovigilance https://www.raps.org/news-and-articles/news-articles/2025/5/recon-trump-signs-order-to-lower-u-s-drug-prices Regulatory Focus en 2025-05-12 Recon: Trump signs order to lower US drug prices Lillys Zepbound beats Wegovy in weight loss study https://www.raps.org/news-and-articles/news-articles/2025/5/euro-convergence-2025-focuses-on-competing-adapti Regulatory Focus en 2025-05-12 Euro Convergence 2025 focuses on competing, adapting amid global change https://www.raps.org/news-and-articles/news-articles/2025/5/asia-pacific-roundup-india-s-cdsco-seeks-feedback Regulatory Focus en 2025-05-12 Asia-Pacific Roundup: Indias CDSCO seeks feedback on revised biosimilar authorization guidelines https://www.raps.org/news-and-articles/news-articles/2025/5/this-week-at-fda-makary-names-vinay-prasad-to-lead Regulatory Focus en 2025-05-09 This Week at FDA: Makary names Vinay Prasad to lead CBER, more high-level hirings and departures https://www.raps.org/news-and-articles/news-articles/2025/5/ema-proposes-to-incorporate-annex-1-in-gmp-guide-f Regulatory Focus en 2025-05-09 EMA proposes to incorporate Annex 1 in GMP guide for ATMPs https://www.raps.org/news-and-articles/news-articles/2025/5/fda-plans-to-roll-out-ai-agency-wide-for-reviews-i Regulatory Focus en 2025-05-08 FDA plans to roll out AI agency-wide for reviews in June https://www.raps.org/news-and-articles/news-articles/2025/5/recon-verastems-ovarian-cancer-drug-gets-fda-appro Regulatory Focus en 2025-05-08 Recon: Verastems ovarian cancer drug gets FDA approval PhRMA blasts tariffs as industry trade probe comments end https://www.raps.org/news-and-articles/news-articles/2025/5/euro-roundup-swissmedic-mandates-nitrosamine-risk Regulatory Focus en 2025-05-08 Euro Roundup: Swissmedic mandates nitrosamine risk assessments in some applications https://www.raps.org/news-and-articles/news-articles/2025/5/eu-regulators-issue-workplan-for-optimizing-ai-and Regulatory Focus en 2025-05-07 EU regulators issue workplan for optimizing AI and big data https://www.raps.org/news-and-articles/news-articles/2025/5/fda-to-expand-unannounced-foreign-inspections-afte Regulatory Focus en 2025-05-06 FDA to expand unannounced foreign inspections after Trump executive order https://www.raps.org/news-and-articles/news-articles/2025/5/latin-america-roundup-proposed-peru-agency-overhau Regulatory Focus en 2025-05-06 Latin America Roundup: Proposed Peru agency overhaul sparks concern https://www.raps.org/news-and-articles/news-articles/2025/5/recon-fda-names-vinay-prasad-as-cber-director-ver Regulatory Focus en 2025-05-06 Recon: FDA names Vinay Prasad as CBER director Vertex halts trial of mRNA treatment for cystic fibrosis https://www.raps.org/news-and-articles/news-articles/2025/5/fra-regulatory-certification-credential Regulatory Focus en 2025-05-06 Ready for a career in regulatory affairs The new FRA credential is for you https://www.raps.org/news-and-articles/news-articles/2025/5/experts-maintain-inspection-readiness-despite-rece Regulatory Focus en 2025-05-05 Experts: Maintain inspection readiness despite recent upheaval at FDA https://www.raps.org/news-and-articles/news-articles/2025/5/recon-fda-to-convene-adcomm-for-capricors-dmd-ther Regulatory Focus en 2025-05-05 Recon: FDA to convene adcomm for Capricors DMD therapy Trump wants drugmakers to agree to lower prices to offset tax cuts https://www.raps.org/news-and-articles/news-articles/2025/5/asia-pacific-roundup-malaysia-s-mda-seeks-feedback Regulatory Focus en 2025-05-05 Asia-Pacific Roundup: Malaysias MDA seeks feedback on changes to medical device exemption processes https://www.raps.org/news-and-articles/news-articles/2025/5/in-reversal-fda-rehires-staff-tasked-with-releasin Regulatory Focus en 2025-05-05 In reversal, FDA rehires staff tasked with releasing public records https://www.raps.org/news-and-articles/news-articles/2025/5/this-week-at-fda-hhs-to-require-placebo-studies-fo Regulatory Focus en 2025-05-02 This Week at FDA: HHS to require placebo studies for vaccines, Makary says no planned FDA reorg, and more https://www.raps.org/news-and-articles/news-articles/2025/5/tarver-asks-for-patience-from-industry-as-cdrh-und Regulatory Focus en 2025-05-02 Tarver asks for patience from industry as CDRH undergoes changes https://www.raps.org/news-and-articles/news-articles/2025/5/senator-appropriators-decry-deep-potential-cuts-to Regulatory Focus en 2025-05-01 Senate appropriators decry deep potential cuts to NIH budget https://www.raps.org/news-and-articles/news-articles/2025/5/medcon-experts-offer-guidance-on-meeting-fda-s-hei Regulatory Focus en 2025-05-01 MedCon: Experts offer guidance on meeting FDAs heightened cybersecurity requirements https://www.raps.org/news-and-articles/news-articles/2025/5/euro-roundup-swiss-federal-council-advances-effort Regulatory Focus en 2025-05-01 Euro Roundup: Swiss Federal Council advances effort to ease import of FDA-authorized devices https://www.raps.org/news-and-articles/news-articles/2025/5/recon-rfj-jr-will-reportedly-require-placebo-contr Regulatory Focus en 2025-05-01 Recon: RFK Jr will reportedly require placebo-controlled studies for new vaccines WHO to support use of weight-loss drugs worldwide https://www.raps.org/news-and-articles/news-articles/2025/4/fda-sends-warning-letters-to-amazon,-three-otc-dru Regulatory Focus en 2025-04-30 FDA sends warning letters to Amazon, three OTC drugmakers, and a drug compounder https://www.raps.org/news-and-articles/news-articles/2025/4/study-data-lacking-for-ai-enabled-medical-devices Regulatory Focus en 2025-04-30 Study: Data lacking for AI-enabled medical devices cleared by FDA https://www.raps.org/news-and-articles/news-articles/2025/4/study-fda-approved-five-drugs-to-treat-rare-diseas Regulatory Focus en 2025-04-29 Study: FDA approved five drugs to treat rare diseases using RWE in 2020-2022 https://www.raps.org/news-and-articles/news-articles/2025/4/expert-calls-executive-order-on-federal-probationa Regulatory Focus en 2025-04-29 Expert calls executive order on federal probationary workers unlawful https://www.raps.org/news-and-articles/news-articles/2025/4/medcon-experts-discuss-approaches-to-large-scale-d Regulatory Focus en 2025-04-29 MedCon: Experts discuss approaches to large-scale data collection and management https://www.raps.org/news-and-articles/news-articles/2025/4/recon-makary-says-fda-wont-reorganize-product-cent Regulatory Focus en 2025-04-29 Recon: Makary says FDA wont reorganize product centers Merck to spend 1B on US factory to produce Keytruda https://www.raps.org/news-and-articles/news-articles/2025/4/medcon-fda-officials-review-common-medical-device Regulatory Focus en 2025-04-28 MedCon: FDA officials review common medical device compliance pitfalls https://www.raps.org/news-and-articles/news-articles/2025/4/advanced-manufacturing-industry-tells-fda-process Regulatory Focus en 2025-04-28 Advanced manufacturing: Industry tells FDA process modeling is sufficient for batch uniformity https://www.raps.org/news-and-articles/news-articles/2025/4/asia-pacific-roundup-drap-advises-firms-in-pakista Regulatory Focus en 2025-04-28 Asia-Pacific Roundup: DRAP advises firms in Pakistan on preventing DEG, EG contamination https://www.raps.org/news-and-articles/news-articles/2025/4/recon-merck-kgaa-to-buy-springworks-for-over-$3b; Regulatory Focus en 2025-04-28 Recon: Merck KGaA to buy SpringWorks for over 3B US tariffs could increase drug spending by 51B per year https://www.raps.org/news-and-articles/news-articles/2025/4/this-week-at-fda-fda-takes-aim-at-synthetic-food-d Regulatory Focus en 2025-04-25 This Week at FDA: FDA takes aim at synthetic food dyes, OMB proposes reclassifying policy staff https://www.raps.org/news-and-articles/news-articles/2025/4/medcon-expert-offers-considerations-for-risk-manag Regulatory Focus en 2025-04-25 MedCon: Expert offers considerations for risk management inputs https://www.raps.org/news-and-articles/news-articles/2025/4/240-industry-partners,-global-regulators,-and-more Regulatory Focus en 2025-04-25 240 Industry Partners, Global Regulators, and More Gather in Columbus for MedCon 2025 https://www.raps.org/news-and-articles/news-articles/2025/4/experts-look-to-states-and-the-courts-for-shifts-i Regulatory Focus en 2025-04-24 Experts: Look to states and the courts for shifts in vaccine policy https://www.raps.org/news-and-articles/news-articles/2025/4/medcon-fda-officials-review-qmsr-as-deadline-appro Regulatory Focus en 2025-04-24 MedCon: FDA officials review QMSR as deadline approaches https://www.raps.org/news-and-articles/news-articles/2025/4/recon-fda-delays-novavax-covid-vaccine-approval-e Regulatory Focus en 2025-04-24 Recon: FDA delays Novavax COVID vaccine approval European drugmakers push for higher prices https://www.raps.org/news-and-articles/news-articles/2025/4/euro-roundup-efpia,-medtech-europe-comment-on-comm Regulatory Focus en 2025-04-24 Euro Roundup: EFPIA, MedTech Europe comment on Commissions life sciences strategy https://www.raps.org/news-and-articles/news-articles/2025/4/device-makers-warned-for-unauthorized-modification Regulatory Focus en 2025-04-23 Device makers warned for unauthorized modifications, cGMP violations https://www.raps.org/news-and-articles/news-articles/2025/4/medcon-fda-officials-say-vip-is-win-win-for-agenc Regulatory Focus en 2025-04-23 MedCon: FDA officials say VIP is win-win for agency and industry https://www.raps.org/news-and-articles/news-articles/2025/4/advamed-ai-medtech-companies-facing-more-risk-with Regulatory Focus en 2025-04-22 AdvaMed: AI medtech companies facing more risk with uncertainties at FDA https://www.raps.org/news-and-articles/news-articles/2025/4/fda-seeks-input-on-using-hl7-fhir-standard-for-col Regulatory Focus en 2025-04-22 FDA seeks input on using HL7 FHIR standard for collecting RWD https://www.raps.org/news-and-articles/news-articles/2025/4/latin-america-roundup-top-anvisa-regulator-laments Regulatory Focus en 2025-04-22 Latin America Roundup: Top ANVISA regulator laments personnel crunch https://www.raps.org/news-and-articles/news-articles/2025/4/recon-fda-announces-three-leadership-hires-roche Regulatory Focus en 2025-04-22 Recon: FDA announces three leadership hires Roche to invest 50B in US to avoid tariffs https://www.raps.org/news-and-articles/news-articles/2025/4/europe-s-pharmaceutical-industry-wants-more-clarit Regulatory Focus en 2025-04-21 Europes pharmaceutical industry wants more clarity on ICHs modeling guideline https://www.raps.org/news-and-articles/news-articles/2025/4/fda-cites-firms-for-marketing-without-proper-autho Regulatory Focus en 2025-04-21 FDA cites firms for marketing without proper authorization, failing to maintain sterile environment https://www.raps.org/news-and-articles/news-articles/2025/4/asia-pacific-roundup-pmda-outlines-initiatives-to Regulatory Focus en 2025-04-21 Asia-Pacific Roundup: PMDA outlines initiatives to promote pediatric drug development in Japan https://www.raps.org/news-and-articles/news-articles/2025/4/recon-fda-clears-dupixent-for-treating-chronic-hiv Regulatory Focus en 2025-04-21 Recon: FDA clears Dupixent for treating chronic hives Administration sets new direction for AI https://www.raps.org/news-and-articles/news-articles/2025/4/ich-releases-overhauled-stability-guideline-for-co Regulatory Focus en 2025-04-17 ICH releases overhauled stability guideline for consultation https://www.raps.org/news-and-articles/news-articles/2025/4/this-week-at-fda-proposed-hhs-budget-would-slash-f Regulatory Focus en 2025-04-17 This Week at FDA: Proposed HHS budget would slash funding, drugmakers worried about FDA staff cuts https://www.raps.org/news-and-articles/news-articles/2025/4/recon-work-stalls-after-fda-staff-cuts;-indian-med Regulatory Focus en 2025-04-17 Recon: Work stalls after FDA staff cuts Indian medtechs react to US tariff plans https://www.raps.org/news-and-articles/news-articles/2025/4/euro-roundup-european-commission-seeks-feedback-on Regulatory Focus en 2025-04-17 Euro Roundup: European Commission seeks feedback on medical countermeasures strategy https://www.raps.org/news-and-articles/news-articles/2025/4/industry-supports-fda-s-draft-guidance-on-weight-m Regulatory Focus en 2025-04-16 Industry supports FDAs draft guidance on weight management drugs, suggests some refinements https://www.raps.org/news-and-articles/news-articles/2025/4/timeliness,-more-guidance-sought-for-ema-early-int Regulatory Focus en 2025-04-16 Timeliness, more guidance sought for EMA early interaction meetings https://www.raps.org/news-and-articles/news-articles/2025/4/kendall-ciriaco-regulatory-compliance-rcc Regulatory Focus en 2025-04-16 The EU MDR is unique An RCC credential helped Kendall Ciriaco conquer it https://www.raps.org/news-and-articles/news-articles/2025/4/industry-groups-call-for-changes-to-fda-s-guidance Regulatory Focus en 2025-04-15 Industry groups call for changes to FDAs guidance on managing AI-enabled medical devices https://www.raps.org/news-and-articles/news-articles/2025/4/trump-administration-investigating-national-securi Regulatory Focus en 2025-04-15 Trump administration investigating national security risk of imported drugs https://www.raps.org/news-and-articles/news-articles/2025/4/ema,-hma-recommend-steps-to-address-potential-radi Regulatory Focus en 2025-04-15 EMA, HMA recommend steps to address potential radiopharmaceuticals shortages https://www.raps.org/news-and-articles/news-articles/2025/4/recon-ec-authorizes-eisai,-biogen-alzheimer-s-drug Regulatory Focus en 2025-04-15 Recon: EC authorizes Eisai, Biogen Alzheimers drug for early treatment CDC advisers begin review of vaccine guidelines https://www.raps.org/news-and-articles/news-articles/2025/4/ogd-officials-offer-advice-on-andas,-post-crl-scie Regulatory Focus en 2025-04-14 OGD officials offer advice on ANDAs, post-CRL scientific meetings https://www.raps.org/news-and-articles/news-articles/2025/4/stakeholders-seek-clarity-in-fda-s-ai-in-regulator Regulatory Focus en 2025-04-14 Stakeholders seek clarity in FDAs AI in regulatory decision-making draft guidance https://www.raps.org/news-and-articles/news-articles/2025/4/software-as-medical-device-applicable-requirements Regulatory Focus en 2025-04-14 Software as medical device: Applicable requirements for market entry in the EU and US https://www.raps.org/news-and-articles/news-articles/2025/4/asia-pacific-roundup-india-to-study-regulatory-bot Regulatory Focus en 2025-04-14 Asia-Pacific Roundup India to study regulatory bottlenecks in drug, device supply chains https://www.raps.org/news-and-articles/news-articles/2025/4/recon-fda-to-replace-some-fired-workers-with-contr Regulatory Focus en 2025-04-14 Recon: FDA to replace some fired workers with contractors Pfizer abandons development of GLP-1 weight-loss drug https://www.raps.org/news-and-articles/news-articles/2025/4/this-week-at-fda-kennedy-warns-of-‘deep-state-in-f Regulatory Focus en 2025-04-11 This Week at FDA: Kennedy warns of Deep State in FDA address, some FDA reviewers granted limited telework https://www.raps.org/news-and-articles/news-articles/2025/4/fda-official-details-common-reasons-for-missing-an Regulatory Focus en 2025-04-11 FDA official details common reasons for missing ANDA review dates https://www.raps.org/news-and-articles/news-articles/2025/4/fda-seeks-to-reduce-animal-testing-requirements-fo Regulatory Focus en 2025-04-11 FDA seeks to reduce animal testing requirements for mAbs, other drugs https://www.raps.org/news-and-articles/news-articles/2025/4/fda-official-says-data-integrity-issues-are-the-ma Regulatory Focus en 2025-04-10 FDA official says data integrity issues are the main reason for ANDA delays https://www.raps.org/news-and-articles/news-articles/2025/4/recon-fda-allowing-some-reviewers-to-telework-tru Regulatory Focus en 2025-04-10 Recon: FDA allowing some reviewers to telework Trump threatens tariffs on prescription drugs https://www.raps.org/news-and-articles/news-articles/2025/4/euro-roundup-drug-and-device-industries-lobby-eu-t Regulatory Focus en 2025-04-10 Euro Roundup: Drug and device industries lobby EU to shape response to US tariff blitz https://www.raps.org/news-and-articles/news-articles/2025/4/former-fda-commissioner-warns-about-losing-a-gener Regulatory Focus en 2025-04-09 Former FDA commissioner warns about losing a generation of scientists https://www.raps.org/news-and-articles/news-articles/2025/4/ema-adopts-reflection-paper-on-rwe-from-noninterve Regulatory Focus en 2025-04-08 EMA adopts reflection paper on RWE from noninterventional studies https://www.raps.org/news-and-articles/news-articles/2025/4/laser-hair-removal-company-cited-for-cgmp-violatio Regulatory Focus en 2025-04-08 Laser hair removal company cited for cGMP violations https://www.raps.org/news-and-articles/news-articles/2025/4/latin-america-roundup-digemid-director-resigns-ami Regulatory Focus en 2025-04-08 Latin America Roundup: DIGEMID director resigns amid IV solution deaths https://www.raps.org/news-and-articles/news-articles/2025/4/recon-trump-administration-boosts-2026-medicare-ad Regulatory Focus en 2025-04-08 Recon: Trump administration boosts 2026 Medicare Advantage payments Federal commission urges US to invest 15B in biotech to counter China https://www.raps.org/news-and-articles/news-articles/2025/4/imdrf-guidance-details-when-regulators-should-shar Regulatory Focus en 2025-04-07 IMDRF guidance details when regulators should share postmarket surveillance reports https://www.raps.org/news-and-articles/news-articles/2025/4/sources-layoffs-could-impact-fda-s-inspection-capa Regulatory Focus en 2025-04-07 Sources: Layoffs could impact FDAs inspection capacity https://www.raps.org/news-and-articles/news-articles/2025/4/asia-pacific-roundup-australia-s-tga-tracks-10-dro Regulatory Focus en 2025-04-07 Asia-Pacific Roundup: Australias TGA tracks 10 drop in GMP clearance backlog since mid-October peak https://www.raps.org/news-and-articles/news-articles/2025/4/recon-marks-says-kennedy-s-team-sought-nonexisten Regulatory Focus en 2025-04-07 Recon: Marks says Kennedys team sought nonexistent data on vaccines Novo to invest 109B to increase Ozempic, Wegovy production in Brazil https://www.raps.org/news-and-articles/news-articles/2025/4/this-week-at-fda-kennedy-says-some-fired-staff-wil Regulatory Focus en 2025-04-04 This Week at FDA: Kennedy says some fired staff will be reinstated, judge rules against FDAs LDT rule, and more https://www.raps.org/news-and-articles/news-articles/2025/4/study-finds-use-of-cancer-medications-declines-aft Regulatory Focus en 2025-04-04 Study finds use of cancer medications declines after withdrawal of accelerated approval https://www.raps.org/news-and-articles/news-articles/2025/4/australia-regulatory-affairs-conference-mtaa Regulatory Focus en 2025-04-04 RAPS and MTAA Open Registration for Australia Regulatory Device Summit 2025 https://www.raps.org/news-and-articles/news-articles/2025/4/makary-tells-fda-staff-to-keep-an-open-mind-to-sol Regulatory Focus en 2025-04-03 Makary asks FDA staff to keep an open mind to solve chronic health problems https://www.raps.org/news-and-articles/news-articles/2025/4/recon-fda-rejects-aldeyras-eye-disease-drug-senate Regulatory Focus en 2025-04-03 Recon: FDA rejects Aldeyras eye disease drug Senate confirms Dr Oz to lead CMS https://www.raps.org/news-and-articles/news-articles/2025/4/euro-roundup-ema-seeks-feedback-on-plans-to-cut-th Regulatory Focus en 2025-04-03 Euro Roundup: EMA seeks feedback on plans to cut the clinical data needed for biosimilar approval https://www.raps.org/news-and-articles/news-articles/2025/4/fda-uncovers-‘significant-data-integrity-concerns Regulatory Focus en 2025-04-02 FDA uncovers significant data integrity concerns at Indian CRO https://www.raps.org/news-and-articles/news-articles/2025/4/fda-reissues-sex-specific-data-guidance-after-sani Regulatory Focus en 2025-04-02 FDA reissues sex-specific data guidance after sanitizing anything considered DEI-related https://www.raps.org/news-and-articles/news-articles/2025/4/thousands-of-fda-staff-fired-in-latest-rif Regulatory Focus en 2025-04-01 Thousands of FDA staff fired in latest RIF https://www.raps.org/news-and-articles/news-articles/2025/4/politicians-react-to-hhs-and-fda-firings-during-om Regulatory Focus en 2025-04-01 Politicians react to HHS and FDA firings during OMUFA and cybersecurity hearings https://www.raps.org/news-and-articles/news-articles/2025/3/recon-drugmakers-petition-trump-for-phased-tariffs Regulatory Focus en 2025-04-01 Recon: Drugmakers petition Trump for phased tariffs Texas judge overturns FDAs LDT regulation https://www.raps.org/news-and-articles/news-articles/2025/3/sources-fda-staff-being-told-to-take-laptops-home Regulatory Focus en 2025-03-31 Sources: FDA staff being told to take laptops home in anticipation of RIF email https://www.raps.org/news-and-articles/news-articles/2025/3/former-fda-officials-experts-decry-hhs-staff-cuts Regulatory Focus en 2025-03-31 Former FDA officials, experts decry HHS staff cuts https://www.raps.org/news-and-articles/news-articles/2025/3/marks-resigns-blames-kennedy-for-spreading-misin Regulatory Focus en 2025-03-31 Marks resigns, blames Kennedy for spreading misinformation and lies https://www.raps.org/news-and-articles/news-articles/2025/3/recon-drugmakers-sink-after-marks-ouster-lilly-s Regulatory Focus en 2025-03-31 Recon: Drugmakers sink after Marks ouster Lillys drug slashes genetic heart disease risk in late-stage trial https://www.raps.org/news-and-articles/news-articles/2025/3/asia-pacific-roundup-malaysia-s-mda-shares-guidanc Regulatory Focus en 2025-03-31 Asia-Pacific Roundup: Malaysias MDA shares guidance on conformity assessment of devices cleared overseas https://www.raps.org/news-and-articles/news-articles/2025/3/this-week-at-fda-hhs-reorg-features-deep-fda-staff Regulatory Focus en 2025-03-28 This Week at FDA: HHS reorg features deep FDA staff cuts Makary, Bhattacharya confirmed for FDA and NIH https://www.raps.org/news-and-articles/news-articles/2025/3/fda-finds-data-integrity-problems-in-recent-warnin Regulatory Focus en 2025-03-28 FDA finds data integrity problems in recent warning letters https://www.raps.org/news-and-articles/news-articles/2025/3/industry-officials-varied-global-postapproval-chan Regulatory Focus en 2025-03-27 Industry officials: Varied global postapproval change requirement pose challenges for drugmakers https://www.raps.org/news-and-articles/news-articles/2025/3/hhs-to-cut-10,000-more-jobs-across-hhs,-including Regulatory Focus en 2025-03-27 HHS to cut 10,000 more jobs across HHS, including 3,500 from FDA https://www.raps.org/news-and-articles/news-articles/2025/3/euro-roundup-ema-outlines-improvements-to-medical Regulatory Focus en 2025-03-27 Euro Roundup: EMA outlines improvements to medical device advice pilot https://www.raps.org/news-and-articles/news-articles/2025/3/recon-hhs-plans-to-cut-10,000-jobs-across-departme Regulatory Focus en 2025-03-27 Recon: HHS plans to cut 10,000 jobs across department FDA having difficulty meeting product reviews after layoffs https://www.raps.org/news-and-articles/news-articles/2025/3/senate-confirms-makary-and-bhattacharya-to-lead-fd Regulatory Focus en 2025-03-26 Senate confirms Makary and Bhattacharya to lead FDA, NIH https://www.raps.org/news-and-articles/news-articles/2025/3/dia-europe-ema-to-release-new-ai-work-plan Regulatory Focus en 2025-03-26 DIA Europe: EMA to release new AI work plan https://www.raps.org/news-and-articles/news-articles/2025/3/life-after-the-fda-career-paths-for-former-regulat Regulatory Focus en 2025-03-26 Life after the FDA: Career paths for former regulators https://www.raps.org/news-and-articles/news-articles/2025/3/experts-commonality-exists-in-international-ai-reg Regulatory Focus en 2025-03-25 Experts: Commonality exists in international AI regulation, but collaboration requires new approaches https://www.raps.org/news-and-articles/news-articles/2025/3/industry-groups-call-for-significant-reforms-to-md Regulatory Focus en 2025-03-25 Industry groups call for significant reforms to MDR, IVDR https://www.raps.org/news-and-articles/news-articles/2025/3/dexcom-cited-for-cgmp-violations Regulatory Focus en 2025-03-25 Dexcom cited for cGMP violations https://www.raps.org/news-and-articles/news-articles/2025/3/latin-america-roundup-cofepris-updates-gmp-guideli Regulatory Focus en 2025-03-25 Latin America Roundup: COFEPRIS updates GMP guidelines, beefs up new molecules committee https://www.raps.org/news-and-articles/news-articles/2025/3/recon-gsk-reviews-whether-shingles-jab-reduces-dem Regulatory Focus en 2025-03-25 Recon: GSK reviews whether shingles jab reduces dementia risk Axsome ADHD hits goal in late-stage trial https://www.raps.org/news-and-articles/news-articles/2025/3/dia-europe-variations-regulation-expected-to-ease Regulatory Focus en 2025-03-24 DIA Europe: Variations regulation expected to ease postapproval changes for pharmaceuticals https://www.raps.org/news-and-articles/news-articles/2025/3/stakeholders-ask-fda-to-consolidate-accelerated-ap Regulatory Focus en 2025-03-24 Stakeholders ask FDA to consolidate accelerated approval guidances, clarify trial assessments https://www.raps.org/news-and-articles/news-articles/2025/3/asia-pacific-roundup-japan-s-pmda-starts-offering Regulatory Focus en 2025-03-24 Asia-Pacific Roundup: Japans PMDA starts offering consultation services from new US office https://www.raps.org/news-and-articles/news-articles/2025/3/recon-novo-licenses-chinese-biotech-s-obesity-cand Regulatory Focus en 2025-03-24 Recon: Novo licenses Chinese biotechs obesity candidate for up to 2B 23andMe files for bankruptcy https://www.raps.org/news-and-articles/news-articles/2025/3/this-week-at-fda-rto-challenges,-measles-response Regulatory Focus en 2025-03-21 This Week at FDA: RTO challenges, measles response criticism, and FDAs new infant formula plan https://www.raps.org/news-and-articles/news-articles/2025/3/dia-europe-eu-regulators-report-steady-progress-in Regulatory Focus en 2025-03-21 DIA Europe: EU regulators report steady progress in RWD acceptance https://www.raps.org/news-and-articles/news-articles/2025/3/experts-warn-against-decoupling-safety-and-effecti Regulatory Focus en 2025-03-21 Experts warn against decoupling safety and effectiveness from FDA approval https://www.raps.org/news-and-articles/news-articles/2025/3/establishing-and-maintaining-the-right-level-of-cl Regulatory Focus en 2025-03-21 Establishing and maintaining the right level of clinical evidence under the EU IVDR https://www.raps.org/news-and-articles/news-articles/2025/3/dia-europe-expert-says-risk-pyramid-can-determine Regulatory Focus en 2025-03-20 DIA Europe: Expert says risk pyramid can determine whether a device requires AI Act conformity assessment https://www.raps.org/news-and-articles/news-articles/2025/3/euro-roundup-medtech-europe-report-cites-admin-bur Regulatory Focus en 2025-03-20 Euro Roundup: MedTech Europe report cites admin burdens under IVDR, MDR amid flurry of activity https://www.raps.org/news-and-articles/news-articles/2025/3/recon-fda-warns-aspen-pharmacare-for-sterility-iss Regulatory Focus en 2025-03-20 Recon: FDA warns Aspen Pharmacare for sterility issues at major facility EMA OKs AI tool in fatty liver disease studies https://www.raps.org/news-and-articles/news-articles/2025/3/some-fda-staff-considering-quitting-due-to-trump-s Regulatory Focus en 2025-03-19 Some FDA staff considering quitting due to Trumps RTO policy https://www.raps.org/news-and-articles/news-articles/2025/3/dia-europe-ich-updates-on-pregnant,-breastfeeding Regulatory Focus en 2025-03-19 DIA Europe: ICH updates on pregnant, breastfeeding individuals in clinical trials, patient engagement https://www.raps.org/news-and-articles/news-articles/2025/3/experts-trump-s-fda-moves-create-uncertainty,-oppo Regulatory Focus en 2025-03-18 Experts: Trumps FDA moves create uncertainty, opportunities for other regulators https://www.raps.org/news-and-articles/news-articles/2025/3/study-nearly-one-third-of-device-adverse-event-rep Regulatory Focus en 2025-03-18 Study: Nearly one-third of device adverse event reports were late or missing data https://www.raps.org/news-and-articles/news-articles/2025/3/recon-sarepta-reports-death-of-teen-who-received-d Regulatory Focus en 2025-03-18 Recon: Sarepta reports death of teen who received Duchenne gene therapy Novartis to slash 427 jobs while revamping cardiovascular business https://www.raps.org/news-and-articles/news-articles/2025/3/fda-s-return-to-office-chaos,-probationary-workers Regulatory Focus en 2025-03-17 FDAs return-to-office chaos, probationary workers reinstated, and demotion fears https://www.raps.org/news-and-articles/news-articles/2025/3/study-fda-offers-flexibility,-expedited-review-to Regulatory Focus en 2025-03-17 Study: FDA offers flexibility, expedited review to first-in-class drugs more often than EMA https://www.raps.org/news-and-articles/news-articles/2025/3/recon-astrazeneca-extends-cancer-drugs-reach-with Regulatory Focus en 2025-03-17 Recon: AstraZeneca extends cancer drugs reach with EsoBiotec 1B purchase Top 10 US drugs losing exclusivity this year https://www.raps.org/news-and-articles/news-articles/2025/3/asia-pacific-roundup-singapore-s-hsa-seeks-feedbac Regulatory Focus en 2025-03-17 Asia-Pacific Roundup: Singapores HSA seeks feedback on medical device cybersecurity best practices https://www.raps.org/news-and-articles/news-articles/2025/3/this-week-at-fda-more-hhs,-fda-cuts-expected-soon; Regulatory Focus en 2025-03-14 This Week at FDA: More HHS, FDA cuts expected soon Congress passes stopgap spending bill https://www.raps.org/news-and-articles/news-articles/2025/3/eu-device-expert-warns-manufacturers-not-to-wait-u Regulatory Focus en 2025-03-14 EU device expert warns manufacturers not to wait until the last minute to transition their products https://www.raps.org/news-and-articles/news-articles/2025/3/experts-recommend-being-tactful,-concise,-and-evid Regulatory Focus en 2025-03-14 Experts recommend being tactful, concise, and evidentiary when submitting guidance comments https://www.raps.org/news-and-articles/news-articles/2025/3/experts-strong-design-controls-are-key-to-fda-devi Regulatory Focus en 2025-03-13 Experts: Strong design controls are key to FDA device approval https://www.raps.org/news-and-articles/news-articles/2025/3/fda-makes-flu-vaccine-recommendations-after-cancel Regulatory Focus en 2025-03-13 FDA makes flu vaccine recommendations after canceled VRBPAC, closed-door meeting https://www.raps.org/news-and-articles/news-articles/2025/3/senate-committee-advances-makary-nomination Regulatory Focus en 2025-03-13 Senate committee advances Makary nomination https://www.raps.org/news-and-articles/news-articles/2025/3/rf-quarterly-march-2025-regulatory-project-manage Regulatory Focus en 2025-03-13 RF Quarterly, March 2025: Regulatory project management https://www.raps.org/news-and-articles/news-articles/2025/3/the-biotech-asset-journey-from-early-development-t Regulatory Focus en 2025-03-13 The biotech asset journey: From early development to market-ready success https://www.raps.org/news-and-articles/news-articles/2025/3/transitions-within-transitions-bench-science-to-pr Regulatory Focus en 2025-03-13 Transitions within transitions: Bench science to project management, and more https://www.raps.org/news-and-articles/news-articles/2025/3/threading-the-needle-the-rpm-s-role-in-the-allianc Regulatory Focus en 2025-03-13 Threading the needle: The RPMs role in the alliance setting https://www.raps.org/news-and-articles/news-articles/2025/3/tools-and-technologies-for-regulatory-project-mana Regulatory Focus en 2025-03-13 Tools and technologies for regulatory project management https://www.raps.org/news-and-articles/news-articles/2025/3/recon-white-house-pulls-cdc-director-nomination;-e Regulatory Focus en 2025-03-13 Recon: White House pulls CDC director nomination Endo, Mallinckrodt to merge in 67B M deal https://www.raps.org/news-and-articles/news-articles/2025/3/euro-roundup-commission-proposes-critical-medicine Regulatory Focus en 2025-03-13 Euro Roundup: Commission proposes Critical Medicines Act, receives pushback from industry https://www.raps.org/news-and-articles/news-articles/2025/3/stakeholders-fda-should-align-pulse-oximeter-guida Regulatory Focus en 2025-03-12 Stakeholders: FDA should align pulse oximeter guidance with updated ISO standard https://www.raps.org/news-and-articles/news-articles/2025/3/regulatory-career-sequita-lindsey-interview Regulatory Focus en 2025-03-12 How Sequita Lindsey navigated her way across the US and into a full circle regulatory career https://www.raps.org/news-and-articles/news-articles/2025/3/latin-america-roundup-invima-touts-reform-effort Regulatory Focus en 2025-03-11 Latin America Roundup: INVIMA touts reform effort https://www.raps.org/news-and-articles/news-articles/2025/3/stakeholders-want-fda-to-address-alternatives,-sam Regulatory Focus en 2025-03-11 Stakeholders want FDA to address alternatives, sample retention in biopsy guidance https://www.raps.org/news-and-articles/news-articles/2025/3/recon-bms-buys-cell-therapy-partner-2seventy-bio-f Regulatory Focus en 2025-03-11 Recon: BMS buys cell therapy partner 2seventy bio for 286M Zydus buys majority stake in French device maker Amplitude https://www.raps.org/news-and-articles/news-articles/2025/3/fda-admonishes-chinese-device-testing-lab-for-fals Regulatory Focus en 2025-03-11 FDA admonishes Chinese device testing lab for falsified studies, copied data https://www.raps.org/news-and-articles/news-articles/2025/3/ema-spells-out-data-access-policy-for-shortage-mon Regulatory Focus en 2025-03-10 EMA spells out data access policy for shortage monitoring platform https://www.raps.org/news-and-articles/news-articles/2025/3/fda-reviewers,-inspectors,-and-investigators-exclu Regulatory Focus en 2025-03-10 FDA reviewers, inspectors, and investigators excluded from 25K buyout offer https://www.raps.org/news-and-articles/news-articles/2025/3/recon-novo-nordisk-s-next-generation-obesity-thera Regulatory Focus en 2025-03-10 Recon: Novo Nordisks next-generation obesity therapy falters in diabetes study Sun Pharma to acquire Checkpoint Therapeutics for 355M https://www.raps.org/news-and-articles/news-articles/2025/3/asia-pacific-roundup-tga-confirms-refusal-to-regis Regulatory Focus en 2025-03-10 Asia-Pacific Roundup: TGA confirms refusal to register Leqembi in Alzheimers after appeal https://www.raps.org/news-and-articles/news-articles/2025/3/fda-s-accelerated-approval-guidance-gets-pushback Regulatory Focus en 2025-03-07 FDAs accelerated approval guidance gets pushback from industry https://www.raps.org/news-and-articles/news-articles/2025/3/experts-propose-restricting-trademarks-on-accelera Regulatory Focus en 2025-03-07 Experts propose restricting trademarks on accelerated approval drugs to speed confirmatory trials https://www.raps.org/news-and-articles/news-articles/2025/3/this-week-at-fda-nomination-hearings,-fda-lease-ca Regulatory Focus en 2025-03-07 This Week at FDA: Nomination hearings, FDA lease cancellations, and more https://www.raps.org/news-and-articles/news-articles/2025/3/makary-commits-to-review-fda-staff-cuts,-vrbpac-ca Regulatory Focus en 2025-03-06 Makary commits to review FDA staff cuts, VRBPAC cancelation in Senate confirmation hearing https://www.raps.org/news-and-articles/news-articles/2025/3/euro-roundup-eu-alliance-recommends-harmonized-sto Regulatory Focus en 2025-03-06 Euro Roundup: EU alliance recommends harmonized stockpiling requirements to prevent drug shortages https://www.raps.org/news-and-articles/news-articles/2025/3/recon-judge-bars-compounders-from-making-copies-of Regulatory Focus en 2025-03-06 Recon: Judge bars compounders from making copies of Lillys weight loss drugs PTAB invalidates two Moderna COVID vaccine patents https://www.raps.org/news-and-articles/news-articles/2025/3/fda-s-st-louis-drug-testing-lab-to-remain-open-des Regulatory Focus en 2025-03-05 FDAs St Louis drug testing lab to remain open despite DOGE claim https://www.raps.org/news-and-articles/news-articles/2025/3/usp-publishes-list-of-vulnerable-medicines-suscept Regulatory Focus en 2025-03-05 USP publishes list of vulnerable medicines susceptible to shortages https://www.raps.org/news-and-articles/news-articles/2025/3/doge-claims-$30m-savings-from-canceling-30-fda-lea Regulatory Focus en 2025-03-04 DOGE claims 30M savings from canceling 30 FDA leases https://www.raps.org/news-and-articles/news-articles/2025/3/fda-warns-indian-firm-over-cleanliness-and-poor-re Regulatory Focus en 2025-03-04 FDA warns Indian firm over cleanliness and poor record keeping, US drugmaker over investigation failures https://www.raps.org/news-and-articles/news-articles/2025/3/opdp-s-first-enforcement-letter-of-2025-sent-to-de Regulatory Focus en 2025-03-04 OPDPs first enforcement letter of 2025 sent to Dexcel over multiple myeloma drug exhibit https://www.raps.org/news-and-articles/news-articles/2025/3/recon-us-health-agencies-make-early-retirement-off Regulatory Focus en 2025-03-04 Recon: US health agencies make early retirement offer to staff South Africa probes Novo, Sanofi over insulin practices https://www.raps.org/news-and-articles/news-articles/2025/3/experts-cuts-at-fda-could-jeopardize-us-standing-i Regulatory Focus en 2025-03-03 Experts: Cuts at FDA could jeopardize US standing in clinical research, product innovation https://www.raps.org/news-and-articles/news-articles/2025/3/stakeholders-seek-clarity,-use-of-international-st Regulatory Focus en 2025-03-03 Stakeholders seek clarity, use of international standards in FDA protocol deviations guidance https://www.raps.org/news-and-articles/news-articles/2025/3/recon-house-democrats-question-rfk-jr-over-health Regulatory Focus en 2025-03-03 Recon: House Democrats question RFK Jr over health agency firings EMA reaffirms positive recommendation for Alzheimers drug Leqembi https://www.raps.org/news-and-articles/news-articles/2025/3/asia-pacific-roundup-pmda-website-promotes-bringin Regulatory Focus en 2025-03-03 Asia-Pacific Roundup: PMDA website promotes bringing products to Japanese market https://www.raps.org/news-and-articles/news-articles/2025/2/this-week-at-fda-makary-confirmation-hearing,-hhs Regulatory Focus en 2025-02-28 This Week at FDA: Makary confirmation hearing, HHS to limit notice and comment for rules https://www.raps.org/news-and-articles/news-articles/2025/2/stakeholders-take-issue-with-fda-s-guidance-on-dru Regulatory Focus en 2025-02-28 Stakeholders take issue with FDAs guidance on drugs with mutagenic potential https://www.raps.org/news-and-articles/news-articles/2025/2/controlled-correspondence-fda-offers-advice-for-ge Regulatory Focus en 2025-02-28 Controlled correspondence: FDA offers advice for generic sponsors https://www.raps.org/news-and-articles/news-articles/2025/2/flu-vaccine-advisory-committee-meeting-cancelation Regulatory Focus en 2025-02-27 Flu vaccine advisory committee meeting cancellation raises concerns about HHS future https://www.raps.org/news-and-articles/news-articles/2025/2/recon-eli-lilly-to-invest-$27b-in-us-drug-manufact Regulatory Focus en 2025-02-27 Recon: Eli Lilly to invest 27B in US drug manufacturing Indias CDSCO to streamline export processes https://www.raps.org/news-and-articles/news-articles/2025/2/euro-roundup-uk-consultation-finds-support-for-ret Regulatory Focus en 2025-02-27 Euro Roundup: UK consultation finds support for retaining EU medtech laws https://www.raps.org/news-and-articles/news-articles/2025/2/fda,-industry-look-to-revisit-regulatory-framework Regulatory Focus en 2025-02-26 FDA, industry look to revisit regulatory framework for HCTPs https://www.raps.org/news-and-articles/news-articles/2025/2/ema-publishes-work-plans-for-infectious-diseases-a Regulatory Focus en 2025-02-25 EMA publishes work plans for infectious diseases and oncology https://www.raps.org/news-and-articles/news-articles/2025/2/stakeholders-seek-clarification,-flexibility,-expa Regulatory Focus en 2025-02-25 Stakeholders seek clarification, flexibility, expansion of CGT guidance https://www.raps.org/news-and-articles/news-articles/2025/2/latin-america-roundup-mexico-s-patent-office,-(1) Regulatory Focus en 2025-02-25 Latin America Roundup: Mexicos patent office, COFEPRIS sign agreement on drug patents https://www.raps.org/news-and-articles/news-articles/2025/2/recon-lilly-to-lower-price-of-zepbound-vials;-j-j Regulatory Focus en 2025-02-25 Recon: Lilly to lower price of Zepbound vials JJ alleges Samsung breached Stelara biosimilar contract https://www.raps.org/news-and-articles/news-articles/2025/2/hhs-tells-staff-they-are-not-required-to-respond-t Regulatory Focus en 2025-02-24 HHS tells staff they are not required to respond to DOGE email https://www.raps.org/news-and-articles/news-articles/2025/2/fda-rehires-some-laid-off-staff,-though-some-fear Regulatory Focus en 2025-02-24 FDA rehires some laid-off staff, though some fear lasting damage to trust https://www.raps.org/news-and-articles/news-articles/2025/2/european-commission-launches-consultation-on-elect Regulatory Focus en 2025-02-24 European Commission launches consultation on electronic instructions for use https://www.raps.org/news-and-articles/news-articles/2025/2/expanding-global-access-to-complex-generics-the-ca Regulatory Focus en 2025-02-24 Expanding global access to complex generics: The case for regulatory convergence https://www.raps.org/news-and-articles/news-articles/2025/2/asia-pacific-roundup-pakistan-s-drap-gains-powers Regulatory Focus en 2025-02-24 Asia-Pacific Roundup: Pakistans DRAP gains powers to invest research fund in regulatory infrastructure https://www.raps.org/news-and-articles/news-articles/2025/2/recon-cavazzoni-returns-to-pfizer-as-cmo;-sk-capit Regulatory Focus en 2025-02-24 Recon: Cavazzoni returns to Pfizer as CMO SK Capital to acquire Bluebird Bio for below 30M https://www.raps.org/news-and-articles/news-articles/2025/2/advamed-urges-trump-administration-to-reverse-fda Regulatory Focus en 2025-02-21 AdvaMed urges Trump administration to reverse FDA layoffs https://www.raps.org/news-and-articles/news-articles/2025/2/this-week-at-fda-fda-layoffs,-resignations,-and-mo Regulatory Focus en 2025-02-21 This Week at FDA: FDA layoffs, resignations, and more https://www.raps.org/news-and-articles/news-articles/2025/2/trump-administration-s-defense-of-ldt-rule-catches Regulatory Focus en 2025-02-21 Trump administrations defense of LDT rule catches legal expert by surprise https://www.raps.org/news-and-articles/news-articles/2025/2/wilson-bryan-return-to-office-mandate-will-‘weaken Regulatory Focus en 2025-02-20 Wilson Bryan: Return-to-office mandate will weaken FDA, impact hiring https://www.raps.org/news-and-articles/news-articles/2025/2/recon-us-cdc-postpones-february-vaccine-advisory-m Regulatory Focus en 2025-02-20 Recon: US CDC postpones February vaccine advisory meeting AstraZeneca acquires FibroGens China unit https://www.raps.org/news-and-articles/news-articles/2025/2/euro-roundup-ema-shares-strategy-for-implementing Regulatory Focus en 2025-02-20 Euro Roundup: EMA shares strategy for implementing ICH M12 drug interaction study guideline https://www.raps.org/news-and-articles/news-articles/2025/2/experts-fda-layoffs-will-slow-device-reviews,-impa Regulatory Focus en 2025-02-19 Experts: FDA layoffs will slow device reviews, impact decision making https://www.raps.org/news-and-articles/news-articles/2025/2/warning-letters-issued-for-cgmp-violations,-refusi Regulatory Focus en 2025-02-18 Warning letters issued for cGMP violations, refusing entry, and falsifying documents https://www.raps.org/news-and-articles/news-articles/2025/2/recon-fda-staff-reviewing-musk-s-neuralink-among-t Regulatory Focus en 2025-02-18 Recon: FDA staff reviewing Musks Neuralink among those fired Bavarian Nordic nabs FDA approval for chikungunya vaccine https://www.raps.org/news-and-articles/news-articles/2025/2/firing-of-fda-probationary-staff-creates-widesprea Regulatory Focus en 2025-02-17 Firing of FDA probationary staff creates widespread uncertainty https://www.raps.org/news-and-articles/news-articles/2025/2/stakeholders-seek-clarity,-case-studies-on-patient Regulatory Focus en 2025-02-17 Stakeholders seek clarity, case studies on patient experience data in applications https://www.raps.org/news-and-articles/news-articles/2025/2/recon-amid-regulatory-shakeups,-drugmakers-schedul Regulatory Focus en 2025-02-17 Recon: Amid regulatory shakeups, drugmakers schedule meeting with Trump next week FDA clears GSKs meningococcal combo jab https://www.raps.org/news-and-articles/news-articles/2025/2/asia-pacific-roundup-tga-reopens-consultation-on-i Regulatory Focus en 2025-02-17 Asia-Pacific Roundup: TGA reopens consultation on IV potassium scheduling https://www.raps.org/news-and-articles/news-articles/2025/2/this-week-at-fda-trump-fires-thousands-of-federal Regulatory Focus en 2025-02-14 This Week at FDA: Trump fires thousands of federal workers, Kennedy sworn in as HHS secretary, and more https://www.raps.org/news-and-articles/news-articles/2025/2/gottlieb-fda-cds-ai-classification-‘at-odds-with-2 Regulatory Focus en 2025-02-14 Gottlieb: FDA CDS AI classification at odds with 21st Century Cures https://www.raps.org/news-and-articles/news-articles/2025/2/ema-proposes-new-guideline-on-model-informed-drug Regulatory Focus en 2025-02-14 EMA proposes new guideline on model-informed drug development https://www.raps.org/news-and-articles/news-articles/2025/2/ema-s-revised-reflection-paper-offers-‘snapshot-of Regulatory Focus en 2025-02-13 EMAs revised reflection paper offers snapshot of animal testing alternatives https://www.raps.org/news-and-articles/news-articles/2025/2/rfk-jr-confirmed-as-hhs-secretary Regulatory Focus en 2025-02-13 RFK Jr confirmed as HHS secretary https://www.raps.org/news-and-articles/news-articles/2025/2/recon-j-j-and-sanofi-halt-e-coli-vaccine-study-ove Regulatory Focus en 2025-02-13 Recon: JJ and Sanofi halt Ecoli vaccine study over weak efficacy data Pfizer nabs new FDA indication for Adcetris https://www.raps.org/news-and-articles/news-articles/2025/2/euro-roundup-swissmedic-updates-position-on-decent Regulatory Focus en 2025-02-13 Euro Roundup: Swissmedic updates position on decentralized clinical trials https://www.raps.org/news-and-articles/news-articles/2025/2/pic-s-establishes-cooperative-agreement-with-afric Regulatory Focus en 2025-02-12 PICS establishes cooperative agreement with African Union Development Agency https://www.raps.org/news-and-articles/news-articles/2025/2/experts-fda-staff-worried-about-unfinished-work,-k Regulatory Focus en 2025-02-12 Experts: FDA staff worried about unfinished work, keeping their jobs https://www.raps.org/news-and-articles/news-articles/2025/2/drugmakers-receive-fda-warning-letter-for-cgmp-vio Regulatory Focus en 2025-02-11 Drugmakers receive FDA warning letter for cGMP violations, failure to obtain IND approval https://www.raps.org/news-and-articles/news-articles/2025/2/latin-america-roundup-argentina-president-announce Regulatory Focus en 2025-02-11 Latin America Roundup: Argentina president announces intent to withdraw from WHO https://www.raps.org/news-and-articles/news-articles/2025/2/recon-germany-s-merck-in-talks-to-acquire-springwo Regulatory Focus en 2025-02-11 Recon: Germanys Merck in talks to acquire SpringWorks Judge orders FDA, CDC to restore deleted portions websites https://www.raps.org/news-and-articles/news-articles/2025/2/european-commission-announces-pilot-for-coordinate Regulatory Focus en 2025-02-10 European Commission announces pilot for coordinated assessment of clinical investigations https://www.raps.org/news-and-articles/news-articles/2025/2/recon-states-sue-to-stop-cuts-to-nih-research-fund Regulatory Focus en 2025-02-10 Recon: States sue to stop cuts to NIH research funds AbbVie nabs FDA approval for novel antibiotic https://www.raps.org/news-and-articles/news-articles/2025/2/ema-launches-early-scientific-advice-program-for-h Regulatory Focus en 2025-02-10 EMA launches early scientific advice program for high-risk medical devices https://www.raps.org/news-and-articles/news-articles/2025/2/asia-pacific-roundup-pmda-discusses-changes-to-war Regulatory Focus en 2025-02-10 Asia-Pacific Roundup: PMDA discusses changes to warning letters https://www.raps.org/news-and-articles/news-articles/2025/2/this-week-federal-workforce-cuts,-trump-buyout-off Regulatory Focus en 2025-02-07 This Week: Federal workforce cuts, Trump buyout offer delayed, and FDAs RTO https://www.raps.org/news-and-articles/news-articles/2025/2/trumps-10-for-1-order-puts-pressure-on-fda-to-find Regulatory Focus en 2025-02-07 Trumps 10-for-1 order puts pressure on FDA to find regulations to nix https://www.raps.org/news-and-articles/news-articles/2025/2/ema-adopts-guideline-on-requirements-for-clinical Regulatory Focus en 2025-02-07 EMA adopts guideline on requirements for clinical-stage ATMPs https://www.raps.org/news-and-articles/news-articles/2025/2/fda-warns-indian-api-supplier-or-data-integrity-la Regulatory Focus en 2025-02-06 FDA warns Indian API supplier or data integrity lapses, Chinese contract lab for inadequate testing https://www.raps.org/news-and-articles/news-articles/2025/2/stakeholders-seek-more-in-person-meetings-and-fast Regulatory Focus en 2025-02-06 Stakeholders seek more in-person meetings and faster guidance development from FDA https://www.raps.org/news-and-articles/news-articles/2025/2/recon-trump-preparing-order-to-cut-federal-health Regulatory Focus en 2025-02-06 Recon: Trump preparing order to cut federal health workforce JJ inks 14B deal with Intra-Cellular https://www.raps.org/news-and-articles/news-articles/2025/2/euro-roundup-ema-seeks-feedback-on-approaches-to-q Regulatory Focus en 2025-02-06 Euro Roundup: EMA seeks feedback on approaches to qualifying novel, non-mutagenic impurities https://www.raps.org/news-and-articles/news-articles/2025/2/drug,-device-makers-scramble-for-tariff-exemptions Regulatory Focus en 2025-02-05 Drug, device makers scramble for tariff exemptions, warn of supply disruptions https://www.raps.org/news-and-articles/news-articles/2025/2/regulators-report-on-progress-toward-implementing Regulatory Focus en 2025-02-04 Regulators report on progress toward implementing IDMP https://www.raps.org/news-and-articles/news-articles/2025/2/kennedy-nomination-clears-hurdle,-heads-to-senate Regulatory Focus en 2025-02-04 Kennedy nomination clears hurdle, heads to Senate floor for final vote https://www.raps.org/news-and-articles/news-articles/2025/2/recon-fda-approves-supernus-parkinson-s-drug-devic Regulatory Focus en 2025-02-04 Recon: FDA approves Supernus Parkinsons drug-device combo Uganda launches vaccine trial for Sudan Ebola strain https://www.raps.org/news-and-articles/news-articles/2025/2/mhra-drafts-mrna-cancer-immunotherapy-guidance Regulatory Focus en 2025-02-03 MHRA drafts mRNA cancer immunotherapy guidance https://www.raps.org/news-and-articles/news-articles/2025/2/study-sponsors-often-submit-different-clinical-evi Regulatory Focus en 2025-02-03 Study: Sponsors often submit different clinical evidence to FDA, EMA, for cell and gene therapies https://www.raps.org/news-and-articles/news-articles/2025/2/recon-fda-oks-xenotransplantation-clinical-trial-f Regulatory Focus en 2025-02-03 Recon: FDA OKs xenotransplantation clinical trial from United Therapeutics Trump tariffs may raise cost of drugs and devices https://www.raps.org/news-and-articles/news-articles/2025/2/asia-pacific-roundup-tga-seeks-feedback-on-plans-t Regulatory Focus en 2025-02-03 Asia-Pacific Roundup: TGA seeks feedback on plans to cut medtech fees, raise other charges https://www.raps.org/news-and-articles/news-articles/2025/1/a-note-from-your-raps-eu-board-chair Regulatory Focus en 2025-02-03 A note from your RAPS EU Board Chair https://www.raps.org/news-and-articles/news-articles/2025/1/fda-s-recent-warning-letters-target-bimo-violation Regulatory Focus en 2025-01-31 FDAs recent warning letters target BIMO violations, unapproved products https://www.raps.org/news-and-articles/news-articles/2025/1/this-week-at-fda-kennedy-faces-senate-scrutiny,-tr Regulatory Focus en 2025-01-31 This Week at FDA: Kennedy faces Senate scrutiny, Trumps buyout offer to federal employees https://www.raps.org/news-and-articles/news-articles/2025/1/study-finds-variation-in-evidence-for-fda-approval Regulatory Focus en 2025-01-31 Study finds variation in evidence for FDA approval of novel psychiatric drugs https://www.raps.org/news-and-articles/news-articles/2025/1/cmc-s-contribution-to-women-s-health-globally-the Regulatory Focus en 2025-01-31 CMCs contribution to womens health globally: The case of the vaginal ring https://www.raps.org/news-and-articles/news-articles/2025/1/regulatory-affairs-certification-rac-rcc-autumn-24 Regulatory Focus en 2025-01-31 These professionals earned their RAC or RCC credentials in Autumn 2024 https://www.raps.org/news-and-articles/news-articles/2025/1/kennedy-s-contentious-nomination-hearings-hinge-on Regulatory Focus en 2025-01-30 Kennedys contentious nomination hearings hinge on vaccine, abortion policy https://www.raps.org/news-and-articles/news-articles/2025/1/euro-roundup-ema-sets-july-implementation-date-for Regulatory Focus en 2025-01-30 Euro Roundup: EMA sets July implementation date for ICH GCP guideline https://www.raps.org/news-and-articles/news-articles/2025/1/recon-takeda-ceo-weber-to-step-down;-merck-halts-p Regulatory Focus en 2025-01-30 Recon: Takeda CEO Weber to step down Merck halts PAH drug trial early on strong efficacy data https://www.raps.org/news-and-articles/news-articles/2025/1/mea-medtech-regulatory-conference-2025-recap Regulatory Focus en 2025-01-30 135 Global Regulators, Health Authorities, Notified Bodies and Industry Partners Gather in Dubai for 2025 MEA MedTech Regulatory Summit https://www.raps.org/news-and-articles/news-articles/2025/1/mrg-and-raps-to-collaborate-on-regulatory-training Regulatory Focus en 2025-01-30 MRG and RAPS to Collaborate on Regulatory Training for the Middle East https://www.raps.org/news-and-articles/news-articles/2025/1/imdrf-finalizes-good-machine-learning-practice,-so Regulatory Focus en 2025-01-29 IMDRF finalizes good machine learning practice, software risk documents https://www.raps.org/news-and-articles/news-articles/2025/1/combination-products-europe-2025-recap Regulatory Focus en 2025-01-29 150 Global Regulators, Health Authorities, Notified Bodies and Industry Partners Gather in Brussels for 2025 Combination Products in the EU https://www.raps.org/news-and-articles/news-articles/2025/1/latin-america-roundup-agencies-face-uncertainties Regulatory Focus en 2025-01-28 Latin America Roundup: Agencies face uncertainties over US WHO withdrawal, USAID suspension https://www.raps.org/news-and-articles/news-articles/2025/1/stakeholders-ask-fda-to-harmonize-oligonucleotide Regulatory Focus en 2025-01-28 Stakeholders ask FDA to harmonize oligonucleotide-based therapeutics guidances https://www.raps.org/news-and-articles/news-articles/2025/1/recon-fda-approves-ozempic-for-to-reduce-kidney-di Regulatory Focus en 2025-01-28 Recon: FDA approves Ozempic to reduce kidney disease progression CDC ordered to immediately halt work with WHO https://www.raps.org/news-and-articles/news-articles/2025/1/stakeholders-disagree-over-fda-s-regulatory-approa Regulatory Focus en 2025-01-27 Stakeholders disagree over FDAs regulatory approach to generative AI https://www.raps.org/news-and-articles/news-articles/2025/1/recon-eisai,-biogen-nab-fda-win-for-once-a-month-l Regulatory Focus en 2025-01-27 Recon: Eisai, Biogen nab FDA win for once-a-month Leqembi maintenance dose Sage rejects 469M Biogen buyout https://www.raps.org/news-and-articles/news-articles/2025/1/asia-pacific-roundup-japan-s-pmda-shares-thinking Regulatory Focus en 2025-01-27 Asia-Pacific Roundup: Japans PMDA shares thinking on showing clinical efficacy in chronic skin condition https://www.raps.org/news-and-articles/news-articles/2025/1/this-week-trump-signs-slew-of-eo,-appoints-new-off Regulatory Focus en 2025-01-24 This Week: Trump signs slew of EO, appoints new officials at FDA https://www.raps.org/news-and-articles/news-articles/2025/1/experts-trump-executive-orders-create-foundation-f Regulatory Focus en 2025-01-24 Experts: Trump executive orders create foundation for whats to come https://www.raps.org/news-and-articles/news-articles/2025/1/health-agencies-recommend-best-practices-for-using Regulatory Focus en 2025-01-24 Health agencies recommend best practices for using surrogate endpoints https://www.raps.org/news-and-articles/news-articles/2025/1/cder-announces-new-guidance-agenda-for-2025 Regulatory Focus en 2025-01-23 CDER announces new guidance agenda for 2025 https://www.raps.org/news-and-articles/news-articles/2025/1/recon-purdue,-sacklers-ink-$7-4b-national-opioid-s Regulatory Focus en 2025-01-23 Recon: Purdue, Sacklers ink 74B national opioid settlement RKF Jr slated for Senate committee hearings next week https://www.raps.org/news-and-articles/news-articles/2025/1/euro-roundup-politicians-call-for-‘substantial-ref Regulatory Focus en 2025-01-23 Euro Roundup: Politicians call for substantial reform of MHRA https://www.raps.org/news-and-articles/news-articles/2025/1/incell-warned-for-marketing-unapproved-product,-cg Regulatory Focus en 2025-01-22 Incell warned for marketing unapproved product, CGMP violations https://www.raps.org/news-and-articles/news-articles/2025/1/combination-products-summit-2025-to-convene-novemb Regulatory Focus en 2025-01-21 Combination Products Summit 2025 to Convene November 13-14 in Providence, Rhode Island https://www.raps.org/news-and-articles/news-articles/2025/1/threading-the-needle-the-rpm-s-role-in-the-allianc Regulatory Focus en 2025-01-21 Threading the needle: The RPMs role in the alliance setting https://www.raps.org/news-and-articles/news-articles/2025/1/european-pharmacopoeia-adopts-new-standards-to-pro Regulatory Focus en 2025-01-21 European Pharmacopoeia adopts new standards to promote the development of mRNA vaccines https://www.raps.org/news-and-articles/news-articles/2025/1/sanofi-issued-warning-letter-for-genzyme-cgmp-fail Regulatory Focus en 2025-01-21 Sanofi issued warning letter for Genzyme cGMP failures https://www.raps.org/news-and-articles/news-articles/2025/1/recon-j-j-s-spravato-gets-fda-approval-for-depress Regulatory Focus en 2025-01-21 Recon: JJs Spravato gets FDA approval for depression monotherapy Chinese biotechs encroach on US drugmakers dominance https://www.raps.org/news-and-articles/news-articles/2025/1/who-guideline-aims-to-facilitate-the-development-o Regulatory Focus en 2025-01-20 WHO guideline aims to facilitate the development of more durable pediatric medicines https://www.raps.org/news-and-articles/news-articles/2025/1/mhra-issues-guidance-on-post-market-surveillance, Regulatory Focus en 2025-01-20 MHRA issues guidance on post-market surveillance, asks for industry feedback https://www.raps.org/news-and-articles/news-articles/2025/1/recon-cms-unveils-second-list-of-drug-price-negoti Regulatory Focus en 2025-01-20 Recon: CMS unveils second list of drug price negotiations Tarver warns on device supply chain vulnerabilities https://www.raps.org/news-and-articles/news-articles/2025/1/fda-draft-guidance-outlines-appropriate-use-of-tis Regulatory Focus en 2025-01-20 FDA draft guidance outlines appropriate use of tissue biopsies in clinical trials https://www.raps.org/news-and-articles/news-articles/2025/1/asia-pacific-roundup-india-s-cdsco-posts-guidance Regulatory Focus en 2025-01-20 Asia-Pacific Roundup: Indias CDSCO posts guidance on validating rapid infectious disease diagnostics https://www.raps.org/news-and-articles/news-articles/2025/1/goodbye-message-califf-says-fda-needs-help-in-batt Regulatory Focus en 2025-01-17 Goodbye message: Califf says FDA needs help in battling misinformation, has deep talent pool to mitigate departures https://www.raps.org/news-and-articles/news-articles/2025/1/this-week-at-fda-cdrh,-cber-annual-reports,-oig-re Regulatory Focus en 2025-01-17 This Week at FDA: CDRH, CBER annual reports, OIG report on accelerated approval https://www.raps.org/news-and-articles/news-articles/2025/1/who-outlines-best-practices-for-continuous-manufac Regulatory Focus en 2025-01-16 WHO outlines best practices for continuous manufacturing https://www.raps.org/news-and-articles/news-articles/2025/1/recon-fda-denies-atara-s-cell-therapy-for-rare-tra Regulatory Focus en 2025-01-16 Recon: FDA denies Ataras cell therapy for rare transplant complication Lilly CEO looks for common cause with Trump administration https://www.raps.org/news-and-articles/news-articles/2025/1/euro-roundup-mhra-shares-guidance-on-incoming-chan Regulatory Focus en 2025-01-16 Euro Roundup: MHRA shares guidance on incoming changes to medtech postmarket surveillance https://www.raps.org/news-and-articles/news-articles/2025/1/fda-officials-clarify-how-diversity-action-plans-i Regulatory Focus en 2025-01-15 FDA officials clarify how diversity action plans intersect with multiregional clinical trials https://www.raps.org/news-and-articles/news-articles/2025/1/fda-warns-five-device-makers-for-quality-system,-c Regulatory Focus en 2025-01-15 FDA warns five device makers for Quality System, CAPA issues https://www.raps.org/news-and-articles/news-articles/2025/1/ich-adopts-e6(r3)-guideline-on-good-clinical-pract Regulatory Focus en 2025-01-14 ICH adopts E6R3 guideline on good clinical practices https://www.raps.org/news-and-articles/news-articles/2025/1/hologic-warned-over-recalled-biozorb-implants Regulatory Focus en 2025-01-14 Hologic warned over recalled BioZorb implants https://www.raps.org/news-and-articles/news-articles/2025/1/fda-proposes-to-modernize-guidance-on-sex,-gender Regulatory Focus en 2025-01-14 FDA proposes to modernize guidance on sex, gender in clinical trials https://www.raps.org/news-and-articles/news-articles/2025/1/recon-ftc-says-pbms-inflated-drug-prices-to-genera Regulatory Focus en 2025-01-14 Recon: FTC says PBMs inflated drug prices to generate 73B in revenue GSK to buy IDRx for 1B upfront https://www.raps.org/news-and-articles/news-articles/2025/1/latin-america-roundup-agencies-continue-shift-to-o Regulatory Focus en 2025-01-14 Latin America Roundup: Agencies continue shift to online processes https://www.raps.org/news-and-articles/news-articles/2025/1/recon-j-j-to-acquire-intra-cellular-therapies-for Regulatory Focus en 2025-01-13 Recon: JJ to acquire Intra-Cellular Therapies for 146 billion Commission publishes EU MDR initiatives for 2025 https://www.raps.org/news-and-articles/news-articles/2025/1/fda-updates-modular-review-program-guidance;-adds Regulatory Focus en 2025-01-13 FDA updates modular review program guidance adds humanitarian device exemptions https://www.raps.org/news-and-articles/news-articles/2025/1/fda-finalizes-guidance-on-reporting-medical-device Regulatory Focus en 2025-01-13 FDA finalizes guidance on reporting medical device shortages https://www.raps.org/news-and-articles/news-articles/2025/1/asia-pacific-roundup-china-publishes-guidelines-in Regulatory Focus en 2025-01-13 Asia-Pacific Roundup: China publishes guidelines in push to reform regulations by 2027 https://www.raps.org/news-and-articles/news-articles/2025/1/this-week-cavazzoni-to-leave-fda,-trump-s-fda-tran Regulatory Focus en 2025-01-10 This Week: Cavazzoni to leave FDA, Trumps FDA transition team, and more https://www.raps.org/news-and-articles/news-articles/2025/1/accelerated-approval-fda-explains-when-it-consider Regulatory Focus en 2025-01-10 Accelerated approval: FDA explains when it considers confirmatory trials underway https://www.raps.org/news-and-articles/news-articles/2025/1/fda-warns-canadian-firm-for-hostile-behavior-durin Regulatory Focus en 2025-01-10 FDA warns Canadian firm for hostile behavior during inspection, two Indian facilities for GMP issues https://www.raps.org/news-and-articles/news-articles/2025/1/fda-proposes-uniform-system-for-classifying-protoc Regulatory Focus en 2025-01-09 FDA proposes uniform system for classifying protocol deviations https://www.raps.org/news-and-articles/news-articles/2025/1/cder-approved-50-novel-drugs-in-2024,-record-numbe Regulatory Focus en 2025-01-09 CDER approved 50 novel drugs in 2024, record number of biosimilars https://www.raps.org/news-and-articles/news-articles/2025/1/euro-roundup-pharma-groups-call-for-phased-rollout Regulatory Focus en 2025-01-09 Euro Roundup: Pharma groups call for phased rollout of electronic product information https://www.raps.org/news-and-articles/news-articles/2025/1/recon-j-j-halts-varipulse-heart-device-launch-foll Regulatory Focus en 2025-01-09 Recon: JJ halts Varipulse heart device launch following stroke reports Seikagakus painkiller may require narrower indication and REMS https://www.raps.org/news-and-articles/news-articles/2025/1/pulse-oximeters-fda-drafts-guidance-to-address-per Regulatory Focus en 2025-01-08 Pulse Oximeters: FDA drafts guidance to address performance disparities https://www.raps.org/news-and-articles/news-articles/2025/1/fda-finalizes-guidance-on-off-label-communications Regulatory Focus en 2025-01-08 FDA finalizes guidance on off-label communications https://www.raps.org/news-and-articles/news-articles/2025/1/fda-finalizes-advanced-manufacturing-technology-de Regulatory Focus en 2025-01-07 FDA finalizes advanced manufacturing technology designation guidance https://www.raps.org/news-and-articles/news-articles/2025/1/fda-proposes-update-to-18-year-guidance-on-develop Regulatory Focus en 2025-01-07 FDA proposes update to 18-year guidance on developing weight loss drugs https://www.raps.org/news-and-articles/news-articles/2025/1/ai-in-drug-development-fda-draft-guidance-addresse Regulatory Focus en 2025-01-07 AI in drug development: FDA draft guidance addresses product lifecycle, risk https://www.raps.org/news-and-articles/news-articles/2025/1/recon-j-j-reports-lung-cancer-therapy-significantl Regulatory Focus en 2025-01-07 Recon: JJ reports lung cancer therapy significantly prolonged survival in study Stryker to buy Inari Medical for 49B https://www.raps.org/news-and-articles/news-articles/2025/1/medcon-2025-announcement-conference Regulatory Focus en 2025-01-07 MedCon 2025 to Convene April 23-25 in Columbus, Ohio https://www.raps.org/news-and-articles/news-articles/2025/1/batch-uniformity-fda-details-testing-approaches-fo Regulatory Focus en 2025-01-06 Batch uniformity: FDA details testing approaches for continuous manufacturing, 3D printing https://www.raps.org/news-and-articles/news-articles/2025/1/fda-issues-draft-guidance-on-developing-and-managi Regulatory Focus en 2025-01-06 FDA issues draft guidance on developing and managing AI-enabled devices https://www.raps.org/news-and-articles/news-articles/2025/1/recon-wuxi-to-sell-irish-facility-to-merck;-lilly Regulatory Focus en 2025-01-06 Recon: WuXi to sell Irish facility to Merck Lilly seeks to join suit against compounders https://www.raps.org/news-and-articles/news-articles/2025/1/how-to-supply-ema-approved-covid-19-vaccines-to-de Regulatory Focus en 2025-01-06 How to supply EMA-approved COVID-19 vaccines to developing countries https://www.raps.org/news-and-articles/news-articles/2025/1/asia-pacific-roundup-tga-seeks-feedback-on-risk-ba Regulatory Focus en 2025-01-06 Asia-Pacific Roundup: TGA seeks feedback on risk-based application audit framework for medical devices https://www.raps.org/news-and-articles/news-articles/2025/1/recon-drugmakers-ring-in-2025-with-new-round-of-pr Regulatory Focus en 2025-01-02 Recon: Drugmakers ring in 2025 with new round of pricing hikes FDA approved 50 new drugs, 11 biologics in 2024 https://www.raps.org/news-and-articles/news-articles/2024/12/fda-updates-gudid-final-guidance Regulatory Focus en 2024-12-19 FDA updates GUDID final guidance https://www.raps.org/news-and-articles/news-articles/2024/12/recon-fda-says-lilly-s-tirzepatide-shortage-is-res Regulatory Focus en 2024-12-19 Recon: FDA says Lillys tirzepatide shortage is resolved Mercks HIV therapy achieves success in pair of Phase 3 trials https://www.raps.org/news-and-articles/news-articles/2024/12/euro-roundup-uk-introduces-legislation-to-speed-up Regulatory Focus en 2024-12-19 Euro Roundup: UK introduces legislation to speed up trial approvals, encourage innovation https://www.raps.org/news-and-articles/news-articles/2024/12/ema,-hma-overhaul-guidance-on-data-transparency-in Regulatory Focus en 2024-12-18 EMA, HMA overhaul guidance on data transparency in MAAs https://www.raps.org/news-and-articles/news-articles/2024/12/deputy-commissioner-bumpus-announces-departure-fro Regulatory Focus en 2024-12-17 Deputy Commissioner Bumpus announces departure from FDA https://www.raps.org/news-and-articles/news-articles/2024/12/pic-s-offers-guidance-on-remote-inspections Regulatory Focus en 2024-12-17 PICS offers guidance on remote inspections https://www.raps.org/news-and-articles/news-articles/2024/12/latin-america-roundup-cofepris-suspends-manufactur Regulatory Focus en 2024-12-17 Latin America Roundup: COFEPRIS suspends manufacturer after bacterial contamination causes infant deaths https://www.raps.org/news-and-articles/news-articles/2024/12/recon-fda-rejects-j-j-s-application-for-injectable Regulatory Focus en 2024-12-17 Recon: FDA rejects JJs application for injectable lung cancer drug BD to pay 175M to settle SEC Alaris pump charges https://www.raps.org/news-and-articles/news-articles/2024/12/european-commission-launches-targeted-consultation Regulatory Focus en 2024-12-16 European Commission launches targeted consultation on MDR, IVDR https://www.raps.org/news-and-articles/news-articles/2024/12/asia-pacific-roundup-japan-s-pmda-seeks-to-curb-me Regulatory Focus en 2024-12-16 Asia-Pacific Roundup: Japans PMDA seeks to curb medical accidents https://www.raps.org/news-and-articles/news-articles/2024/12/recon-novo-to-finalize-its-$16-5b-catalent-acquisi Regulatory Focus en 2024-12-16 Recon: Novo to finalize its 165B Catalent acquisition FDA approves Neurocrines CAH treatment https://www.raps.org/news-and-articles/news-articles/2024/12/this-week-at-fda-more-rfk-vaccine-worries;-cder-la Regulatory Focus en 2024-12-13 This Week at FDA: More RFK vaccine worries CDER launches RWERWD center https://www.raps.org/news-and-articles/news-articles/2024/12/fda-establishes-new-center-to-streamline-new-drug Regulatory Focus en 2024-12-13 FDA establishes new center to streamline new drug development using RWDRWE https://www.raps.org/news-and-articles/news-articles/2024/12/stakeholders-urge-greater-collaboration-to-promote Regulatory Focus en 2024-12-12 Stakeholders urge greater collaboration to promote innovative manufacturing https://www.raps.org/news-and-articles/news-articles/2024/12/recon-mhra-ai-airlock-candidates-selected;-gilead Regulatory Focus en 2024-12-12 Recon: MHRA AI Airlock candidates selected Gilead tests yearly anti-HIV shot https://www.raps.org/news-and-articles/news-articles/2024/12/euro-roundup-mhra-updates-on-medical-device-regula Regulatory Focus en 2024-12-12 Euro Roundup: MHRA updates on medical device regulatory reforms https://www.raps.org/news-and-articles/news-articles/2024/12/advamed,-abbott-ask-fda-to-prioritize-cybersecurit Regulatory Focus en 2024-12-11 AdvaMed, Abbott ask FDA to prioritize cybersecurity, PCCP and LDT guidances next year https://www.raps.org/news-and-articles/news-articles/2024/12/pharmaceutical-groups-say-more-slots-needed-for-jo Regulatory Focus en 2024-12-11 Pharmaceutical groups say more slots needed for joint scientific consultations https://www.raps.org/news-and-articles/news-articles/2024/12/researchers-suggest-fda-needs-authority-to-require Regulatory Focus en 2024-12-10 Researchers suggest FDA needs authority to require pediatric studies for orphan drugs https://www.raps.org/news-and-articles/news-articles/2024/12/patient-preference-information-stakeholders-seek-c Regulatory Focus en 2024-12-10 Patient preference information: Stakeholders seek clarity on terms, postmarket usage https://www.raps.org/news-and-articles/news-articles/2024/12/recon-lilly-plans-to-test-weight-loss-drugs-for-al Regulatory Focus en 2024-12-10 Recon: Lilly plans to test weight-loss drugs for alcohol, drug addiction PhRMA not lobbying against RFK Jr nomination https://www.raps.org/news-and-articles/news-articles/2024/12/ema-updates-guidelines-for-reporting-drug-shortage Regulatory Focus en 2024-12-09 EMA issues guidelines on shortage mitigation, prevention plans https://www.raps.org/news-and-articles/news-articles/2024/12/fda-finalizes-bimo-electronic-submission-guidance Regulatory Focus en 2024-12-09 FDA finalizes BIMO electronic submission guidance https://www.raps.org/news-and-articles/news-articles/2024/12/recon-abbvie-s-parkinson-s-drug-succeeds-in-phase Regulatory Focus en 2024-12-09 Recon: AbbVies Parkinsons drug succeeds in Phase 3 study Mercks Keytruda combo misses survival endpoint in late-stage ovarian cancer study https://www.raps.org/news-and-articles/news-articles/2024/12/rf-quarterly,-december-2024-raps-convergence-2024 Regulatory Focus en 2024-12-09 RF Quarterly, December 2024: RAPS Convergence https://www.raps.org/news-and-articles/news-articles/2024/12/best-practices-for-510(k)-submissions-using-estar Regulatory Focus en 2024-12-09 Best practices for 510k submissions using eSTAR https://www.raps.org/news-and-articles/news-articles/2024/12/unlocking-success-in-medtech-innovation-regulatory Regulatory Focus en 2024-12-09 Unlocking success in medtech innovation: Regulatory challenges for start-ups and spin-offs https://www.raps.org/news-and-articles/news-articles/2024/12/product-quality-review-of-biologics-and-biosimilar Regulatory Focus en 2024-12-09 Product quality review of biologics and biosimilars: Focus on Module 3 issues https://www.raps.org/news-and-articles/news-articles/2024/12/failure-is-not-an-option-how-to-avoid-and-recover Regulatory Focus en 2024-12-09 Failure is not an option: How to avoid and recover from an IND clinical hold https://www.raps.org/news-and-articles/news-articles/2024/12/human-factors-development-navigating-ambiguities; Regulatory Focus en 2024-12-09 Human factors development: Navigating ambiguities creating robust strategies https://www.raps.org/news-and-articles/news-articles/2024/12/fostering-dynamic-partnerships-between-regulatory Regulatory Focus en 2024-12-09 Fostering dynamic partnerships between regulatory and marketing teams https://www.raps.org/news-and-articles/news-articles/2024/12/concurrent-regulatory-submissions-strategies-and-b Regulatory Focus en 2024-12-09 Concurrent regulatory submissions: Strategies and best practices https://www.raps.org/news-and-articles/news-articles/2024/12/asia-pacific-roundup-singapore-s-hsa-starts-samd-c Regulatory Focus en 2024-12-09 Asia-Pacific Roundup: Singapores HSA starts SaMD change management pilot project https://www.raps.org/news-and-articles/news-articles/2024/12/this-week-at-fda-califf-urges-doge-to-work-with-fd Regulatory Focus en 2024-12-06 This Week at FDA: Califf urges DOGE to work with FDA, updates on Hurricane-related shortage concerns, and more https://www.raps.org/news-and-articles/news-articles/2024/12/accelerated-approval-fda-revises-guidance-to-refle Regulatory Focus en 2024-12-05 Accelerated approval: FDA revises guidance to reflect revised withdrawal procedures https://www.raps.org/news-and-articles/news-articles/2024/12/recon-califf-defends-fda-s-record-on-obesity,-food Regulatory Focus en 2024-12-05 Recon: Califf defends FDAs record on obesity, food in Senate hearing UK to limit access to Lillys Mounjaro https://www.raps.org/news-and-articles/news-articles/2024/12/euro-roundup-ema-seeks-feedback-on-regulation-of-w Regulatory Focus en 2024-12-05 Euro Roundup: EMA seeks feedback on regulation of weight control clinical trials in children https://www.raps.org/news-and-articles/news-articles/2024/12/mdcg-provides-guidance-on-clinical-investigation-r Regulatory Focus en 2024-12-04 MDCG provides guidance on clinical investigation reports during EUDAMED transition https://www.raps.org/news-and-articles/news-articles/2024/12/regulatory-policy-forum-recap Regulatory Focus en 2024-12-04 2024 Regulatory Policy Forum Takes an In-Depth Look Into the Once in a Generation Changes to the EU Pharmaceutical Legislation https://www.raps.org/news-and-articles/news-articles/2024/12/final-fda-guidance-on-pccp-includes-clarification Regulatory Focus en 2024-12-03 Final FDA guidance on PCCP includes clarification on version control https://www.raps.org/news-and-articles/news-articles/2024/12/latin-america-roundup-anvisa-to-allow-rolling-subm Regulatory Focus en 2024-12-03 Latin America Roundup: ANVISA to allow rolling submission of clinical trial data https://www.raps.org/news-and-articles/news-articles/2024/12/recon-fda-warns-applied-therapeutics-over-clinical Regulatory Focus en 2024-12-03 Recon: FDA warns Applied Therapeutics over clinical trial handling Roivant to halt sarcoidosis drug development https://www.raps.org/news-and-articles/news-articles/2024/12/fda-issues-reports-on-best-practices-for-communica Regulatory Focus en 2024-12-02 FDA issues reports on best practices for communication, guidance development https://www.raps.org/news-and-articles/news-articles/2024/12/recon-sanofi-planning-€1b-manufacturing-investment Regulatory Focus en 2024-12-02 Recon: Sanofi planning 1B manufacturing investment in Beijing Ex-FDA chief Gottlieb raises concerns about RFK Jr nomination https://www.raps.org/news-and-articles/news-articles/2024/12/asia-pacific-roundup-philippine-fda-improves-opera Regulatory Focus en 2024-12-02 Asia-Pacific Roundup: Philippine FDA improves operating license process for drug, device companies https://www.raps.org/news-and-articles/news-articles/2024/11/this-week-at-fda-trump-nominates-o-neill-for-hhs-d Regulatory Focus en 2024-11-29 This Week at FDA: Trump nominates ONeill for HHS deputy, CDRH presents MDUFA data https://www.raps.org/news-and-articles/news-articles/2024/11/mdcg-guidance-addresses-master-udi-di-labeling-for Regulatory Focus en 2024-11-27 MDCG guidance addresses Master UDI-DI labeling for contact lenses https://www.raps.org/news-and-articles/news-articles/2024/11/fda-drafts-guidance-on-follow-up-testing-for-drug Regulatory Focus en 2024-11-27 FDA drafts guidance on follow up testing for drug candidates with mutagenic potential https://www.raps.org/news-and-articles/news-articles/2024/11/fda-recommends-collecting-ovarian-toxicity-data-in Regulatory Focus en 2024-11-26 FDA recommends collecting ovarian toxicity data in cancer drug trials https://www.raps.org/news-and-articles/news-articles/2024/11/ich-exploring-global-platform-for-reviewing-post-a Regulatory Focus en 2024-11-26 ICH exploring global platform for reviewing post approval CMC changes https://www.raps.org/news-and-articles/news-articles/2024/11/recon-feds-propose-medicare-coverage-of-glp-1s-for Regulatory Focus en 2024-11-26 Recon: Feds propose Medicare coverage of GLP-1s for weight loss Roche purchases CAR-T developer Poseida for 1 billion upfront https://www.raps.org/news-and-articles/news-articles/2024/11/ethylene-oxide-fda-issues-enforcement-discretion-p Regulatory Focus en 2024-11-25 Ethylene oxide: FDA issues enforcement discretion policy for sterilization site changes https://www.raps.org/news-and-articles/news-articles/2024/11/european-commission-issues-q-a-on-phased-implement Regulatory Focus en 2024-11-25 European Commission issues QA on phased implementation of Eudamed https://www.raps.org/news-and-articles/news-articles/2024/11/recon-trump-picks-makary-to-head-fda;-fda-approves Regulatory Focus en 2024-11-25 Recon: Trump picks Makary to head FDA FDA approves BridgeBios Attruby for rare heart condition https://www.raps.org/news-and-articles/news-articles/2024/11/asia-pacific-roundup-tga-seeks-feedback-on-plans-t Regulatory Focus en 2024-11-25 Asia-Pacific Roundup: TGA seeks feedback on plans to adopt 19 international scientific guidelines https://www.raps.org/news-and-articles/news-articles/2024/11/fda-finalizes-guidance-on-510(k)-third-party-revie Regulatory Focus en 2024-11-22 FDA finalizes guidance on 510k third-party reviews https://www.raps.org/news-and-articles/news-articles/2024/11/this-week-at-fda-makary-seen-as-trump-s-top-fda-pi Regulatory Focus en 2024-11-22 This Week at FDA: Makary seen as Trumps top FDA pick, Marks braces for vigorous dialogue on vaccines https://www.raps.org/news-and-articles/news-articles/2024/11/generative-ai-fda-adcomm-makes-recommendations-on Regulatory Focus en 2024-11-22 Generative AI: FDA adcomm makes recommendations on postmarket performance of medical devices https://www.raps.org/news-and-articles/news-articles/2024/11/generative-ai-fda-adcomm-discusses-performance-eva Regulatory Focus en 2024-11-21 Generative AI: FDA adcomm discusses performance evaluation, risk management for medical devices https://www.raps.org/news-and-articles/news-articles/2024/11/recon-trump-reportedly-eying-martin-makary-to-lead Regulatory Focus en 2024-11-21 Recon: Trump reportedly eying Martin Makary to lead FDA Novartis acquires Kate Therapeutics for up to 11B https://www.raps.org/news-and-articles/news-articles/2024/11/euro-roundup-ema-shares-draft-on-data-strategy-for Regulatory Focus en 2024-11-21 Euro Roundup: EMA shares draft on data strategy for EMRN https://www.raps.org/news-and-articles/news-articles/2024/11/fda-warns-chinese-drugmaker-for-refusing-access-du Regulatory Focus en 2024-11-20 FDA warns Chinese drugmaker for refusing access during inspection, Indian firm for data integrity lapses https://www.raps.org/news-and-articles/news-articles/2024/11/stakeholders-seek-changes-to-fda-s-oncology-multir Regulatory Focus en 2024-11-20 Stakeholders seek changes to FDAs oncology multiregional trial guideline https://www.raps.org/news-and-articles/news-articles/2024/11/fda-drafts-q-a-guidance-on-cell-and-gene-therapy-d Regulatory Focus en 2024-11-19 FDA drafts QA guidance on cell and gene therapy development https://www.raps.org/news-and-articles/news-articles/2024/11/latin-america-roundup-cofepris-to-prioritize-revie Regulatory Focus en 2024-11-19 Latin America Roundup: COFEPRIS to prioritize review of mass-purchased medicines https://www.raps.org/news-and-articles/news-articles/2024/11/recon-j-j,-protagonist-tout-phase-3-study-wins-for Regulatory Focus en 2024-11-19 Recon: JJ, Protagonist tout phase 3 study wins for oral IL-23 therapy Bayer buys Japanese rights to Cytokinetics heart drug https://www.raps.org/news-and-articles/news-articles/2024/11/ich-releases-draft-gcp-annex,-midd-guideline Regulatory Focus en 2024-11-18 ICH releases draft GCP annex, MIDD guideline https://www.raps.org/news-and-articles/news-articles/2024/11/ema-proposes-research-on-challenging-regulatory-to Regulatory Focus en 2024-11-18 EMA proposes research on challenging regulatory topics, new research platform https://www.raps.org/news-and-articles/news-articles/2024/11/recon-fda-approves-syndax-leukemia-therapy;-boston Regulatory Focus en 2024-11-18 Recon: FDA approves Syndax leukemia therapy Boston Scientific completes 37B Axonics acquisition https://www.raps.org/news-and-articles/news-articles/2024/11/asia-pacific-roundup-tga-seeks-feedback-on-propose Regulatory Focus en 2024-11-18 Asia-Pacific Roundup: TGA seeks feedback on proposed changes to drug shortage reporting https://www.raps.org/news-and-articles/news-articles/2024/11/mhra-wants-feedback-on-updating-ivd,-medical-devic Regulatory Focus en 2024-11-15 MHRA wants feedback on updating IVD, medical device regulatory framework https://www.raps.org/news-and-articles/news-articles/2024/11/gao-finds-persistent-challenges-in-fda-s-ability-t Regulatory Focus en 2024-11-15 GAO finds persistent challenges in FDAs ability to hire and retain inspectors https://www.raps.org/news-and-articles/news-articles/2024/11/this-week-at-fda-rfk-jr-nominated-to-hhs-secretary Regulatory Focus en 2024-11-15 This Week at FDA: RFK Jr nominated to HHS Secretary, FDA wants feedback on RWE and patient-focused drug development https://www.raps.org/news-and-articles/news-articles/2024/11/study-finds-‘substantial-revenues-for-cancer-drugs Regulatory Focus en 2024-11-15 Study finds substantial revenues for cancer drugs in granted pediatric exclusivity https://www.raps.org/news-and-articles/news-articles/2024/11/fda-again-urges-lawmakers-for-new-notification-aut Regulatory Focus en 2024-11-14 FDA again urges lawmakers for new notification authority, funding to address future pandemics https://www.raps.org/news-and-articles/news-articles/2024/11/ich-touts-significant-milestones”-reached-this-yea Regulatory Focus en 2024-11-14 ICH touts significant milestones reached this year in adopting and advancing guidelines https://www.raps.org/news-and-articles/news-articles/2024/11/recon-fda-raps-merz-over-misleading-instagram-post Regulatory Focus en 2024-11-14 Recon: FDA raps Merz over misleading Instagram posts for wrinkle treatment JJ sues Biden Administration over 340B drug payments https://www.raps.org/news-and-articles/news-articles/2024/11/the-biotech-asset-journey-from-early-development-t Regulatory Focus en 2024-11-14 The biotech asset journey: From early development to market-ready success https://www.raps.org/news-and-articles/news-articles/2024/11/euro-roundup-commissioner-designate-vows-mdr-actio Regulatory Focus en 2024-11-14 Euro Roundup: Commissioner-designate vows MDR action on orphan, pediatric devices in Q1 2025 https://www.raps.org/news-and-articles/news-articles/2024/11/fda-proposes-guidance-for-nonclinical-safety-asses Regulatory Focus en 2024-11-13 FDA proposes guidance for nonclinical safety assessment of oligonucleotide-based drugs https://www.raps.org/news-and-articles/news-articles/2024/11/opdp-reprimands-merz-over-instagram-ad-for-botox-c Regulatory Focus en 2024-11-13 OPDP reprimands Merz over Instagram ad for Botox competitor Xeomin https://www.raps.org/news-and-articles/news-articles/2024/11/califf-‘disappointed-about-election,-warns-of-chan Regulatory Focus en 2024-11-12 Califf disappointed about election, warns of changes at FDA https://www.raps.org/news-and-articles/news-articles/2024/11/mdcg-adds-four-questions-to-vigilance-terms-guidan Regulatory Focus en 2024-11-12 MDCG adds four questions to vigilance terms guidance to comply with MDRIVDR https://www.raps.org/news-and-articles/news-articles/2024/11/recon-pfizer-mulls-over-selling-hospital-drugs-bus Regulatory Focus en 2024-11-12 Recon: Pfizer mulls over selling hospital drugs business AstraZeneca plans 2B for US production, RD boost https://www.raps.org/news-and-articles/news-articles/2024/11/experts-say-rfk-jr-could-play-big-role-in-trump-2 Regulatory Focus en 2024-11-11 Experts say RFK Jr could play big role in Trump 20, FDA leadership to face scrutiny https://www.raps.org/news-and-articles/news-articles/2024/11/recon-abbvie-s-schizophrenia-drug-from-$9b-buyout Regulatory Focus en 2024-11-11 Recon: AbbVies schizophrenia drug from 9B buyout falters in 2 studies FDA lifts hold on Novavax flu-COVID vaccine trials https://www.raps.org/news-and-articles/news-articles/2024/11/asia-pacific-roundup-medsafe-cuts-time-to-complete Regulatory Focus en 2024-11-11 Asia-Pacific Roundup: Medsafe cuts time to complete initial application evaluations https://www.raps.org/news-and-articles/news-articles/2024/11/usp-india-and-china-continue-their-api-manufacturi Regulatory Focus en 2024-11-08 USP: India and China continue their API manufacturing reign https://www.raps.org/news-and-articles/news-articles/2024/11/this-week-at-fda-a-second-trump-term,-rfk-jr-,-and Regulatory Focus en 2024-11-08 This Week at FDA: A second Trump term, RFK Jr, and whats to come https://www.raps.org/news-and-articles/news-articles/2024/11/recon-how-trump-and-rfk-jr-could-reshape-healthcar Regulatory Focus en 2024-11-07 Recon: How Trump and RFK Jr could reshape healthcare Moderna reports slower RSV vaccine sales but better-than-expected COVID vaccine revenue https://www.raps.org/news-and-articles/news-articles/2024/11/euro-roundup-council-s-adoption-of-wastewater-rule Regulatory Focus en 2024-11-07 Euro Roundup: Councils adoption of wastewater rules triggers backlash from pharma industry https://www.raps.org/news-and-articles/news-articles/2024/11/fda-proposes-removing-oral-phenylephrine-from-use Regulatory Focus en 2024-11-07 FDA proposes removing oral phenylephrine from use in nasal decongestants https://www.raps.org/news-and-articles/news-articles/2024/11/industry-groups-spar-over-fda-s-proposed-compoundi Regulatory Focus en 2024-11-06 Industry groups spar over FDAs proposed compounding survey https://www.raps.org/news-and-articles/news-articles/2024/11/experts-notified-body-survey-shows-mdr-ivdr-progre Regulatory Focus en 2024-11-06 Experts: Notified body survey shows MDRIVDR progress despite some snags https://www.raps.org/news-and-articles/news-articles/2024/11/fda-to-test-star-pilot-for-original-applications Regulatory Focus en 2024-11-05 FDA to test STAR pilot for original applications https://www.raps.org/news-and-articles/news-articles/2024/11/stakeholders-want-more-opportunities-to-discuss-mi Regulatory Focus en 2024-11-05 Stakeholders want more opportunities to discuss MIDD with FDA https://www.raps.org/news-and-articles/news-articles/2024/11/latin-america-roundup-paraguay-merges-medicines-an Regulatory Focus en 2024-11-05 Latin America Roundup: Paraguay merges medicines and food agencies https://www.raps.org/news-and-articles/news-articles/2024/11/recon-fda-extends-review-of-merus-cancer-drug;-how Regulatory Focus en 2024-11-05 Recon: FDA extends review of Merus cancer drug How Trump or Harris could affect healthcare policy https://www.raps.org/news-and-articles/news-articles/2024/11/stakeholders-want-more-collaboration,-regulatory-f Regulatory Focus en 2024-11-04 Stakeholders want more collaboration, regulatory flexibility in FDAs new rare disease hub https://www.raps.org/news-and-articles/news-articles/2024/11/recent-cber-warning-letters-target-unapproved-prod Regulatory Focus en 2024-11-04 Recent CBER warning letters target unapproved products, BIMO violations https://www.raps.org/news-and-articles/news-articles/2024/11/recon-fda-approves-journey-s-rosacea-drug;-eu-to-d Regulatory Focus en 2024-11-04 Recon: FDA approves Journeys rosacea drug EU to decide on Novos Catalent acquisition by 6 December https://www.raps.org/news-and-articles/news-articles/2024/11/asia-pacific-roundup-japan-s-pmda-opens-us-first-o Regulatory Focus en 2024-11-04 Asia-Pacific Roundup: Japans PMDA opens US first office, continuing global expansion https://www.raps.org/news-and-articles/news-articles/2024/11/fda-revises-more-than-800-psgs-in-line-with-ich-m1 Regulatory Focus en 2024-11-01 FDA revises more than 800 PSGs in line with ICH M13A https://www.raps.org/news-and-articles/news-articles/2024/11/this-week-at-fda-omufa-ii,-fda-names-new-rare-dise Regulatory Focus en 2024-11-01 This Week at FDA: OMUFA II, FDA names new Rare Disease Innovation Hub leader, and more https://www.raps.org/news-and-articles/news-articles/2024/11/drug-shortages-more-common-in-the-us-than-canada, Regulatory Focus en 2024-11-01 Drug shortages more common in the US than Canada, study finds https://www.raps.org/news-and-articles/news-articles/2024/10/ema-proposes-updated-guideline-on-peripheral-arter Regulatory Focus en 2024-10-31 EMA proposes updated guideline on peripheral arterial occlusive disease treatments https://www.raps.org/news-and-articles/news-articles/2024/10/white-paper-highlights-sbom-challenges-for-medical Regulatory Focus en 2024-10-31 White paper highlights SBOM challenges for medical devices https://www.raps.org/news-and-articles/news-articles/2024/10/recon-baxter-resumes-iv-solution-production-at-hur Regulatory Focus en 2024-10-31 Recon: Baxter resumes IV solution production at hurricane-impacted facility Teva hit with 463M antitrust fine over Copaxone practices https://www.raps.org/news-and-articles/news-articles/2024/10/euro-roundup-commission-seeks-feedback-on-medtech Regulatory Focus en 2024-10-31 Euro Roundup: Commission seeks feedback on medtech joint scientific consultations https://www.raps.org/news-and-articles/news-articles/2024/10/european-commission-q-a-details-shortage-reporting Regulatory Focus en 2024-10-30 European Commission QA details shortage reporting requirements under MDR, IVDR https://www.raps.org/news-and-articles/news-articles/2024/10/notified-body-official-shares-recommendations-for Regulatory Focus en 2024-10-30 Notified body official shares recommendations for successful PMCF plans https://www.raps.org/news-and-articles/news-articles/2024/10/expert-discusses-how-to-avoid-clinical-evaluations Regulatory Focus en 2024-10-29 Expert discusses how to avoid clinical evaluation derailments for medical devices https://www.raps.org/news-and-articles/news-articles/2024/10/mdcg-clarifies-how-ethylene-oxide-is-regulated-und Regulatory Focus en 2024-10-29 MDCG clarifies how ethylene oxide is regulated under MDR, IVDR https://www.raps.org/news-and-articles/news-articles/2024/10/recon-pfizer-raises-outlook-by-$1-5b-over-renewed Regulatory Focus en 2024-10-29 Recon: Pfizer raises outlook by 15B over renewed Paxlovid sales Lilly touts new dosing regimen for Alzheimers drug as potentially safer https://www.raps.org/news-and-articles/news-articles/2024/10/eu-parliament-passes-resolution-citing-‘urgent-nee Regulatory Focus en 2024-10-28 EU Parliament passes resolution citing urgent need for MDRIVDR revision https://www.raps.org/news-and-articles/news-articles/2024/10/recon-abbvie-to-buy-alzheimer-s-biotech-aliada-for Regulatory Focus en 2024-10-28 Recon: AbbVie to buy Alzheimers biotech Aliada for 14B Philips slashes sales forecast after slump in China https://www.raps.org/news-and-articles/news-articles/2024/10/ema-official-reports-on-scientific-advice-pilots-f Regulatory Focus en 2024-10-28 EMA official reports on scientific advice pilots for high-risk and orphan devices https://www.raps.org/news-and-articles/news-articles/2024/10/asia-pacific-roundup-indian-pharmacopoeia-seeks-fe Regulatory Focus en 2024-10-28 Asia-Pacific Roundup: Indian Pharmacopoeia seeks feedback on disinfecting drug production plants https://www.raps.org/news-and-articles/news-articles/2024/10/this-week-at-fda-tarver-named-cdrh-chief,-gop-repo Regulatory Focus en 2024-10-25 This Week at FDA: Tarver named CDRH chief, GOP report critical of HHS COVID vaccine promotion https://www.raps.org/news-and-articles/news-articles/2024/10/tarver-says-clinical-trial-diversity-action-plans Regulatory Focus en 2024-10-24 Tarver says clinical trial diversity action plans are a marketing opportunity https://www.raps.org/news-and-articles/news-articles/2024/10/industry-rejects-fda-s-proposal-for-biosimilar-pro Regulatory Focus en 2024-10-24 Industry rejects FDAs proposal for biosimilar product-specific guidance https://www.raps.org/news-and-articles/news-articles/2024/10/recon-novo-nordisk-asks-fda-to-block-semaglutide-c Regulatory Focus en 2024-10-24 Recon: Novo Nordisk asks FDA to block semaglutide compounding Roche inks potential 1B gene therapy deal with Dyno https://www.raps.org/news-and-articles/news-articles/2024/10/expert-discusses-implications-of-eu-ai-act-‘high-r Regulatory Focus en 2024-10-24 Expert discusses implications of EU AI Act high risk provisions on medical devices https://www.raps.org/news-and-articles/news-articles/2024/10/euro-roundup-britain-proposes-postmarket-surveilla Regulatory Focus en 2024-10-24 Euro Roundup: Britain proposes postmarket surveillance law in first major update to medtech regulations https://www.raps.org/news-and-articles/news-articles/2024/10/stakeholders-disagree-over-need-for-‘urgent-action Regulatory Focus en 2024-10-23 Stakeholders disagree over need for urgent action on MDRIVDR https://www.raps.org/news-and-articles/news-articles/2024/10/fda-drafts-guidance-on-drug-interaction-labeling Regulatory Focus en 2024-10-23 FDA drafts guidance on drug interaction labeling https://www.raps.org/news-and-articles/news-articles/2024/10/mea-regulatory-summitt-mecomed-raps Regulatory Focus en 2024-10-23 Mecomed and RAPS Open Registration for 2025 MEA MedTech Regulatory Summit https://www.raps.org/news-and-articles/news-articles/2024/10/latin-america-roundup-zuniga-named-new-head-of-cof Regulatory Focus en 2024-10-22 Latin America Roundup: Zúñiga named new head of COFEPRIS https://www.raps.org/news-and-articles/news-articles/2024/10/tarver-named-new-cdrh-director Regulatory Focus en 2024-10-22 Tarver named new CDRH director https://www.raps.org/news-and-articles/news-articles/2024/10/recon-fda-rejects-camurus-rare-hormone-disorder-dr Regulatory Focus en 2024-10-22 Recon: FDA rejects Camurus rare hormone disorder drug Amgen to launch Eylea biosimilar in US after appeals court decision https://www.raps.org/news-and-articles/news-articles/2024/10/shuren-lawmakers-should-enable-voluntary-alternati Regulatory Focus en 2024-10-21 Shuren: Lawmakers should enable voluntary alternative pathway, international reliance https://www.raps.org/news-and-articles/news-articles/2024/10/submission-of-single-vs-separate-marketing-applica Regulatory Focus en 2024-10-21 Submission of single vs separate marketing applications for combination products in the US https://www.raps.org/news-and-articles/news-articles/2024/10/recon-sanofi-in-talks-to-sell-its-consumer-busines Regulatory Focus en 2024-10-21 Recon: Sanofi in talks to sell its consumer business Opella Novos Rybelsus cut heart risks in Phase III trial https://www.raps.org/news-and-articles/news-articles/2024/10/asia-pacific-roundup-tga-corrects-misinformation-a Regulatory Focus en 2024-10-21 Asia-Pacific Roundup: TGA corrects misinformation about COVID-19 vaccine contamination https://www.raps.org/news-and-articles/news-articles/2024/10/cdrh-officials-say-pre-submission-meetings-can-imp Regulatory Focus en 2024-10-18 CDRH officials say pre-submission meetings can improve odds for de novo requests https://www.raps.org/news-and-articles/news-articles/2024/10/this-week-at-fda-new-guidances-address-cancer-pros Regulatory Focus en 2024-10-18 This Week at FDA: New guidances address cancer PROs, neurodevelopmental safety studies, and more https://www.raps.org/news-and-articles/news-articles/2024/10/fda-officials-outline-need-for-oversight-of-ai-in Regulatory Focus en 2024-10-17 FDA officials outline need for oversight of AI in healthcare, biomedicine https://www.raps.org/news-and-articles/news-articles/2024/10/recon-abbvie-wins-fda-approval-for-24-hour-parkins Regulatory Focus en 2024-10-17 Recon: AbbVie wins FDA approval for 24-hour Parkinsons infusion treatment FDA expands use of Avadels narcolepsy drug to children 7 and older https://www.raps.org/news-and-articles/news-articles/2024/10/euro-roundup-mep-calls-medtech-rules-a-‘bureaucrat Regulatory Focus en 2024-10-17 Euro Roundup: MEP calls medtech rules a bureaucratic monster as calls for change intensify https://www.raps.org/news-and-articles/news-articles/2024/10/mhra-to-launch-consultation-on-device-internationa Regulatory Focus en 2024-10-16 MHRA to launch consultation on device international reliance plan by years end https://www.raps.org/news-and-articles/news-articles/2024/10/recon-eli-lilly-s-omvoh-bests-j-j-s-stelara-in-lat Regulatory Focus en 2024-10-15 Recon: Eli Lillys Omvoh bests JJs Stelara in late-stage study for Crohns Innovation in the EU medtech market https://www.raps.org/news-and-articles/news-articles/2024/10/health-canada-digital-health-head-says-ai-ml-guida Regulatory Focus en 2024-10-15 Health Canada digital health head says AIML guidance imminent https://www.raps.org/news-and-articles/news-articles/2024/10/study-finds-a-majority-of-new-drug-approvals-subje Regulatory Focus en 2024-10-15 Study finds a majority of new drug approvals subject to PREA requirements have ongoing postmarketing studies https://www.raps.org/news-and-articles/news-articles/2024/10/risk-and-data-availability-key-to-regulating-healt Regulatory Focus en 2024-10-15 Risk and data availability key to regulating health equity in device development https://www.raps.org/news-and-articles/news-articles/2024/10/ema-drafts-concept-paper-for-future-radiopharmaceu Regulatory Focus en 2024-10-15 EMA drafts concept paper for future radiopharmaceuticals guideline https://www.raps.org/news-and-articles/news-articles/2024/10/fda-issues-emergency-compounding-guidance-to-addre Regulatory Focus en 2024-10-14 FDA issues emergency compounding guidance to address drug shortages due to recent hurricanes https://www.raps.org/news-and-articles/news-articles/2024/10/recon-fda-may-rethink-shortage-listing-for-eli-lil Regulatory Focus en 2024-10-14 Recon: FDA may rethink shortage listing for Eli Lillys tirzepatide Pfizer nabs FDA approval for injectable Hympavzi for hemophilia https://www.raps.org/news-and-articles/news-articles/2024/10/asia-pacific-roundup-india-s-cdsco-meets-who-inter Regulatory Focus en 2024-10-14 Asia-Pacific Roundup: Indias CDSCO meets WHO international standards for vaccine regulations https://www.raps.org/news-and-articles/news-articles/2024/10/industry-stakeholders-call-for-changes-to-ich-m14 Regulatory Focus en 2024-10-14 Industry stakeholders call for changes to ICH M14 RWD guideline https://www.raps.org/news-and-articles/news-articles/2024/10/study-most-new-drugs-subject-to-prea-requirements Regulatory Focus en 2024-10-14 Study: Most new drugs subject to PREA requirements have ongoing postmarketing studies https://www.raps.org/news-and-articles/news-articles/2024/10/this-week-at-fda-new-dscsa-exemptions,-hemophilia Regulatory Focus en 2024-10-11 This Week at FDA: New DSCSA exemptions, hemophilia prophylactic approved, and more https://www.raps.org/news-and-articles/news-articles/2024/10/ich-survey-shows-uptick-in-guideline-implementatio Regulatory Focus en 2024-10-11 ICH survey shows uptick in guideline implementation https://www.raps.org/news-and-articles/news-articles/2024/10/240-global-regulators-and-industry-partners-gather Regulatory Focus en 2024-10-11 240 Global Regulators and Industry Partners Gather in Providence for Combination Products Summit 2024 https://www.raps.org/news-and-articles/news-articles/2018/8/rac-exam-prep-advice-tips Regulatory Focus en 2024-10-10 How to prepare for the RAC exam: 9 tips to get your Regulatory Affairs Certification https://www.raps.org/news-and-articles/news-articles/2024/10/eu-regulators-propose-updated-medicines-strategy-t Regulatory Focus en 2024-10-10 EU regulators propose updated medicines strategy to include AI growth, new pharma legislation https://www.raps.org/news-and-articles/news-articles/2024/10/recon-baxter-increases-allocations-of-iv-fluid-ami Regulatory Focus en 2024-10-10 Recon: Baxter increases allocations of IV fluid amid shortages GSK to settle 80,000 Zantac lawsuits for as much as 22B https://www.raps.org/news-and-articles/news-articles/2024/10/latin-america-roundup-regulatory-affairs-at-center Regulatory Focus en 2024-10-10 Latin America Roundup: Regulatory affairs at center of WHO Americas meeting https://www.raps.org/news-and-articles/news-articles/2024/10/euro-roundup-mhra-outlines-steps-to-accelerate-acc Regulatory Focus en 2024-10-10 Euro Roundup: MHRA outlines steps to accelerate access to medical products https://www.raps.org/news-and-articles/news-articles/2024/10/fda-announces-broad-dscsa-exemptions-for-trading-p Regulatory Focus en 2024-10-09 FDA announces broad DSCSA exemptions for trading partners https://www.raps.org/news-and-articles/news-articles/2024/10/lawmakers-urge-fda-to-consider-broad-exemptions-fr Regulatory Focus en 2024-10-08 Lawmakers urge FDA to consider broad exemptions from DSCSA to minimize supply chain disruptions https://www.raps.org/news-and-articles/news-articles/2024/10/mdcg-issues-guidance-and-templates-on-capa-plans Regulatory Focus en 2024-10-08 MDCG issues guidance and templates on CAPA plans https://www.raps.org/news-and-articles/news-articles/2024/10/recon-gsk,-pfizer-rsv-vaccine-sales-drop-in-the-us Regulatory Focus en 2024-10-08 Recon: GSK, Pfizer RSV vaccine sales drop in the US Sage abandons Alzheimers drug after late-stage trial miss https://www.raps.org/news-and-articles/news-articles/2024/10/fda-compliance-official-highlights-priorities,-ret Regulatory Focus en 2024-10-07 FDA compliance official highlights priorities, return to onsite inspections, and warning letter trends https://www.raps.org/news-and-articles/news-articles/2024/10/fda-science-board-recommends-creation-of-centraliz Regulatory Focus en 2024-10-07 FDA Science Board recommends creation of centralized new alternative methods office https://www.raps.org/news-and-articles/news-articles/2024/10/recon-pfizer-wins-rsv-vaccine-patent-fight;-baxter Regulatory Focus en 2024-10-07 Recon: Pfizer wins RSV vaccine patent fight Baxter uncertain when hurricane-hit plant will reopen https://www.raps.org/news-and-articles/news-articles/2024/10/asia-pacific-roundup-india-becomes-imdrf-affiliate Regulatory Focus en 2024-10-07 Asia-Pacific Roundup: India becomes IMDRF affiliate member https://www.raps.org/news-and-articles/news-articles/2024/10/stakeholders-warn-of-potential-burdens-in-fda-s-dr Regulatory Focus en 2024-10-04 Stakeholders warn of potential burdens in FDAs drug delivery guidance https://www.raps.org/news-and-articles/news-articles/2024/10/this-week-at-fda-fda-s-major-reorg-takes-effect,-r Regulatory Focus en 2024-10-04 This Week at FDA: FDAs major reorg takes effect, rare disease grants, and a TAP update https://www.raps.org/news-and-articles/news-articles/2024/10/diversity-action-plans-stakeholders-seek-clarity-o Regulatory Focus en 2024-10-03 Diversity action plans: Stakeholders seek clarity on demographic data, enrollment, and global trials https://www.raps.org/news-and-articles/news-articles/2024/10/recon-texas-ag-sues-insulin-makers,-pbms-over-high Regulatory Focus en 2024-10-03 Recon: Texas AG sues insulin makers, PBMs over high costs Lilly resolves US weight-loss drug shortages https://www.raps.org/news-and-articles/news-articles/2024/10/euro-roundup-commission-seeks-feedback-on-procedur Regulatory Focus en 2024-10-03 Euro Roundup: Commission seeks feedback on procedural rules for joint scientific consultations https://www.raps.org/news-and-articles/news-articles/2024/10/fda-finalizes-q-a-guidance-on-electronic-records-i Regulatory Focus en 2024-10-02 FDA finalizes QA guidance on electronic records in clinical trials https://www.raps.org/news-and-articles/news-articles/2024/10/ema-concerned-about-maa-delays,-working-on-solutio Regulatory Focus en 2024-10-02 EMA concerned about MAA delays, working on solutions https://www.raps.org/news-and-articles/news-articles/2024/10/louisiana-board-report-sheds-light-on-dscsa-adopti Regulatory Focus en 2024-10-01 Louisiana board report sheds light on DSCSA adoption https://www.raps.org/news-and-articles/news-articles/2024/10/fda-pulls-the-trigger-on-major-agency-reorganizati Regulatory Focus en 2024-10-01 FDA pulls the trigger on major agency reorganization https://www.raps.org/news-and-articles/news-articles/2024/9/recon-who-recommends-rsv-antibody-and-vaccine-duri Regulatory Focus en 2024-10-01 Recon: WHO recommends RSV antibody and vaccine during pregnancy JJ to build 2B facility in North Carolina https://www.raps.org/news-and-articles/news-articles/2024/9/califf-calls-for-mandatory-reporting-of-device-sho Regulatory Focus en 2024-09-30 Califf calls for mandatory reporting of device shortages https://www.raps.org/news-and-articles/news-articles/2024/9/ema-adopts-reflection-paper-on-ai-ml-in-drug-devel Regulatory Focus en 2024-09-30 EMA adopts reflection paper on AIML in drug development https://www.raps.org/news-and-articles/news-articles/2024/9/recon-fda-approves-bristol-myers-schizophrenia-dru Regulatory Focus en 2024-09-30 Recon: FDA approves Bristol Myers schizophrenia drug Roche targets 3B in annual obesity drug sales https://www.raps.org/news-and-articles/news-articles/2024/9/apac-roundup-singapore-s-hsa-shares-ectd-specifica Regulatory Focus en 2024-09-30 Asia-Pacific Roundup: Singapores HSA shares eCTD specification package ahead of March launch https://www.raps.org/news-and-articles/news-articles/2024/9/rac-raps-summer-2024-regulatory Regulatory Focus en 2024-09-30 These 130 professionals earned their RAC credentials in summer 2024 https://www.raps.org/news-and-articles/news-articles/2024/9/regulatory-compliance-certification-rcc-summer Regulatory Focus en 2024-09-30 These 36 professionals earned their RCC credentials in summer 2024 https://www.raps.org/news-and-articles/news-articles/2024/9/convergence-cdrh-on-track-to-meet-its-fy-2023-mduf Regulatory Focus en 2024-09-26 Convergence: CDRH on track to meet its FY 2023 MDUFA V performance goals, says Tarver https://www.raps.org/news-and-articles/news-articles/2024/9/fda-official-discusses-agency-s-new-rare-disease-i Regulatory Focus en 2024-09-26 FDA official discusses agencys new Rare Disease Innovation Hub https://www.raps.org/news-and-articles/news-articles/2024/9/recon-pfizer-withdraws-sickle-cell-drug-oxbryta-fr Regulatory Focus en 2024-09-26 Recon: Pfizer withdraws sickle cell drug Oxbryta from worldwide markets Evotec, Novo Nordisk partner on stem cell therapy manufacturing https://www.raps.org/news-and-articles/news-articles/2024/9/euro-roundup-commission-posts-guide-to-validity-of Regulatory Focus en 2024-09-26 Euro Roundup: Commission posts guide to validity of studies for joint clinical assessments https://www.raps.org/news-and-articles/news-articles/2024/9/raps-convergence-conference-highlights-recap Regulatory Focus en 2024-09-26 5 highlights from RAPS Convergence 2024 https://www.raps.org/news-and-articles/news-articles/2024/9/industry-concerned-over-hurdles-in-fda-s-biosimila Regulatory Focus en 2024-09-25 Industry concerned over hurdles in FDAs biosimilars manufacturing changes guidance https://www.raps.org/news-and-articles/news-articles/2024/9/convergence-fda-officials-offer-updates-on-start, Regulatory Focus en 2024-09-24 Convergence: FDA officials offer updates on START, STAR pilots https://www.raps.org/news-and-articles/news-articles/2024/9/fda-releases-three-post-pilot-asca-draft-guidances Regulatory Focus en 2024-09-24 FDA releases three post-pilot ASCA draft guidances https://www.raps.org/news-and-articles/news-articles/2024/9/latin-america-roundup-chile-comptroller-faults-reg Regulatory Focus en 2024-09-24 Latin America Roundup: Chile comptroller faults regulators for lax enforcement https://www.raps.org/news-and-articles/news-articles/2024/9/recon-japan-approves-lilly-s-alzheimer-s-drug;-mhr Regulatory Focus en 2024-09-24 Recon: Japan approves Lillys Alzheimers drug MHRA seeks applicants for AI Airlock https://www.raps.org/news-and-articles/news-articles/2024/9/convergence-fda-official-offers-insights-on-clinic Regulatory Focus en 2024-09-23 Convergence: FDA official offers insights on clinical holds, use of AI at CBER https://www.raps.org/news-and-articles/news-articles/2024/9/recon-zevra-prices-newly-approved-neimann-pick-dis Regulatory Focus en 2024-09-23 Recon: Zevra prices newly approved Neimann-Pick disease drug at 106k per month Novo faces Senate committee grilling over weight loss drug prices https://www.raps.org/news-and-articles/news-articles/2024/9/asia-pacific-roundup-india-updates-pharmacovigilan Regulatory Focus en 2024-09-23 Asia-Pacific Roundup: India updates pharmacovigilance guidance, extending event reporting deadline https://www.raps.org/news-and-articles/news-articles/2024/9/this-week-at-fda-asca-guidances,-new-clinical-tria Regulatory Focus en 2024-09-20 This Week at FDA: ASCA guidances, new clinical trial guidances, and more https://www.raps.org/news-and-articles/news-articles/2024/9/convergence-fda-unlikely-to-meet-tap-pilot-recruit Regulatory Focus en 2024-09-20 Convergence: FDA unlikely to meet TAP pilot recruitment limit for FY 2024 https://www.raps.org/news-and-articles/news-articles/2024/9/convergence-fda-official-reviews-common-bla-defici Regulatory Focus en 2024-09-19 Convergence: FDA official reviews common BLA deficiencies, offers advice on avoiding CRLs https://www.raps.org/news-and-articles/news-articles/2024/9/convergence-experts-offer-advice-on-when-to-submit Regulatory Focus en 2024-09-19 Convergence: Experts offer advice on when to submit a PCCP https://www.raps.org/news-and-articles/news-articles/2024/9/fda-draft-guidance-paves-way-for-more-real-world, Regulatory Focus en 2024-09-19 FDA draft guidance paves way for more real-world, point-of-care clinical trials https://www.raps.org/news-and-articles/news-articles/2024/9/euro-roundup-ema-finalizes-reflection-paper-on-est Regulatory Focus en 2024-09-19 Euro Roundup: EMA finalizes reflection paper on establishing efficacy based on single-arm trials https://www.raps.org/news-and-articles/news-articles/2024/9/recon-fda-rejects-vanda-s-stomach-condition-drug; Regulatory Focus en 2024-09-19 Recon: FDA rejects Vandas stomach condition drug EU authorizes Bavarian mpox vaccine for adolescents https://www.raps.org/news-and-articles/news-articles/2024/9/eu-officials-discuss-advice-pathways,-return-to-of Regulatory Focus en 2024-09-18 EU officials discuss advice pathways, return to office at Convergence https://www.raps.org/news-and-articles/news-articles/2024/9/convergence-listen-to-patients-when-developing-tre Regulatory Focus en 2024-09-18 Convergence: Listen to patients when developing treatments for unmet medical needs, experts say https://www.raps.org/news-and-articles/news-articles/2024/9/studies-find-uneven-uptake-of-biosimilars-as-avail Regulatory Focus en 2024-09-18 Studies find uneven uptake of biosimilars as availability increases https://www.raps.org/news-and-articles/news-articles/2024/9/industry-seeks-phased-in-approach-to-drug-supply-c Regulatory Focus en 2024-09-18 Industry seeks phased-in approach to drug supply chain tracking requirements https://www.raps.org/news-and-articles/news-articles/2024/9/rf-quarterly,-september-2024-artificial-intelligen Regulatory Focus en 2024-09-18 RF Quarterly, September 2024: Artificial intelligence in medical devices https://www.raps.org/news-and-articles/news-articles/2024/9/the-global-regulatory-landscape-for-ai-ml-enabled Regulatory Focus en 2024-09-18 The global regulatory landscape for AIML-enabled medical devices https://www.raps.org/news-and-articles/news-articles/2024/9/ai-driven-strategies-for-enhancing-medical-device Regulatory Focus en 2024-09-18 AI-driven strategies for enhancing medical device regulatory compliance https://www.raps.org/news-and-articles/news-articles/2024/9/the-evolving-role-of-contact-free-ai-devices-in-cl Regulatory Focus en 2024-09-18 The evolving role of contact-free AI devices in clinical trials https://www.raps.org/news-and-articles/news-articles/2024/9/the-role-of-data-in-ai-governance-in-healthcare-a Regulatory Focus en 2024-09-18 The role of data in AI governance in healthcare: A cross-jurisdictional analysis https://www.raps.org/news-and-articles/news-articles/2024/9/machine-learning-best-practices-transparency,-expl Regulatory Focus en 2024-09-18 Machine learning best practices: Transparency, explainability, and medical devices https://www.raps.org/news-and-articles/news-articles/2024/9/convergence-experts-offer-advice-on-leveraging-ai Regulatory Focus en 2024-09-17 Convergence: Experts offer advice on leveraging AI in regulatory https://www.raps.org/news-and-articles/news-articles/2024/9/fda-s-final-guidance-on-dcts-adds-clarity-on-hcp-t Regulatory Focus en 2024-09-17 FDAs final guidance on DCTs adds clarity on HCP task log, inspection requirements, data variability https://www.raps.org/news-and-articles/news-articles/2024/9/study-oncology-accelerated-approvals-are-often-bas Regulatory Focus en 2024-09-17 Study: Oncology accelerated approvals are often based on non-comparative trials evaluating response rate https://www.raps.org/news-and-articles/news-articles/2024/9/recon-express-scripts-sues-ftc-over-pbm-report;-ne Regulatory Focus en 2024-09-17 Recon: Express Scripts sues FTC over PBM report Neuralink brain implant nabs breakthrough device designation https://www.raps.org/news-and-articles/news-articles/2024/9/fda-drafts-guidance-on-multiregional-clinical-tria Regulatory Focus en 2024-09-16 FDA drafts guidance on multiregional clinical trials in oncology https://www.raps.org/news-and-articles/news-articles/2024/9/convergence-2024-to-explore-ai,-workplace-challeng Regulatory Focus en 2024-09-16 Convergence 2024 to explore AI, workplace challenges, unmet medical needs https://www.raps.org/news-and-articles/news-articles/2024/9/recon-astrazeneca-releases-positive-results-on-imf Regulatory Focus en 2024-09-16 Recon: AstraZeneca releases positive results on Imfinzi for bladder cancer Apple gets FDA nod for hearing aid software for earbuds https://www.raps.org/news-and-articles/news-articles/2024/9/apac-roundup-cdsco-releases-draft-guidelines-on-go Regulatory Focus en 2024-09-16 Asia-Pacific Roundup: CDSCO releases draft guidelines on good clinical practices for consultation https://www.raps.org/news-and-articles/news-articles/2024/9/fda-updates-guidance-on-classifying-anda-amendment Regulatory Focus en 2024-09-13 FDA updates guidance on classifying ANDA amendments for GDUFA III https://www.raps.org/news-and-articles/news-articles/2024/9/this-week-at-fda-ectd-4-0,-data-integrity-warnings Regulatory Focus en 2024-09-13 This Week at FDA: eCTDv40, data integrity warnings, and more https://www.raps.org/news-and-articles/news-articles/2024/9/regulatory -landscape-of-ingestible-medical-device Regulatory Focus en 2024-09-13 The regulatory landscape of ingestible medical devices in the United States https://www.raps.org/news-and-articles/news-articles/2024/9/fda-seeks-feedback-on-its-integrated-review-docume Regulatory Focus en 2024-09-12 Integrated assessments: FDA consults on its integrated review documentation https://www.raps.org/news-and-articles/news-articles/2024/9/recon-fda-authorizes-apple-s-airpods-pro-hearing-a Regulatory Focus en 2024-09-12 Recon: FDA authorizes Apples AirPods Pro hearing aid software Moderna slashes RD spending by 11B but praises research advances https://www.raps.org/news-and-articles/news-articles/2024/9/fda-seeks-input-on-its-innovative-manufacturing-te Regulatory Focus en 2024-09-12 FDA seeks input on its innovative manufacturing technology strategy https://www.raps.org/news-and-articles/news-articles/2024/9/euro-roundup-‘slow-and-complex-drug-regulatory-fra Regulatory Focus en 2024-09-12 Euro Roundup: Slow and complex drug regulatory framework blamed for EUs emerging competitive gap https://www.raps.org/news-and-articles/news-articles/2024/7/the-eu-paediatric-regulation-current-status,-futur Regulatory Focus en 2024-09-12 The EU Paediatric Regulation: Current status, future outlook https://www.raps.org/news-and-articles/news-articles/2024/9/approved-provider-rac-credits Regulatory Focus en 2024-09-12 The new RAPS Approved Provider Program: what it means for your organization https://www.raps.org/news-and-articles/news-articles/2024/9/industry-groups-call-for-changes-to-fda-s-guidance Regulatory Focus en 2024-09-10 Industry groups call for changes to FDAs guidance on use-related risk analyses https://www.raps.org/news-and-articles/news-articles/2024/9/pharma,-device-groups-ask-for-more-leeway-to-addre Regulatory Focus en 2024-09-10 Pharma, device groups ask for more leeway to address misinformation https://www.raps.org/news-and-articles/news-articles/2024/9/latin-america-roundup-invima-chief-says-restructur Regulatory Focus en 2024-09-10 Latin America Roundup: INVIMA chief says restructuring will promote faster reviews, greater surveillance https://www.raps.org/news-and-articles/news-articles/2024/9/recon-unitedhealth-to-pull-humira-from-certain-us Regulatory Focus en 2024-09-10 Recon: UnitedHealth to pull Humira from certain US drug reimbursement lists in 2025 US House passes Biosecure Act https://www.raps.org/news-and-articles/news-articles/2024/9/ema,-hma-publish-large-language-model-principles-f Regulatory Focus en 2024-09-09 EMA, HMA publish large language model principles for regulators https://www.raps.org/news-and-articles/news-articles/2024/9/ema-updates-guideline-on-developing-drugs-for-bipo Regulatory Focus en 2024-09-09 EMA updates guideline on developing drugs for bipolar disorder https://www.raps.org/news-and-articles/news-articles/2024/9/recon-us-fda-panels-return-to-normal-and-schedule Regulatory Focus en 2024-09-09 Recon: US FDA panels return to normal and schedule filling up Judge rules that JJ must pay Auris investors over 1 billion for violating merger https://www.raps.org/news-and-articles/news-articles/2024/9/asia-pacific-roundup-drap-changes-fees-for-132-reg Regulatory Focus en 2024-09-09 Asia-Pacific Roundup: DRAP changes fees for 132 regulatory services, raising rates in multiple areas https://www.raps.org/news-and-articles/news-articles/2024/9/this-week-at-fda-inspection-backlog,-tampon-safety Regulatory Focus en 2024-09-06 This Week at FDA: Inspection backlog, tampon safety, and more https://www.raps.org/news-and-articles/news-articles/2024/9/researchers-tout-the-benefits-of-pragmatic-clinica Regulatory Focus en 2024-09-06 Researchers tout the benefits of pragmatic clinical trials https://www.raps.org/news-and-articles/news-articles/2024/9/fda-official-clarifies-cgmp-expectations-for-inves Regulatory Focus en 2024-09-06 FDA official clarifies cGMP expectations for investigational drugs https://www.raps.org/news-and-articles/news-articles/2024/9/fda-updates-patient-preference-guidance-to-span-th Regulatory Focus en 2024-09-05 FDA updates patient preference guidance to span the product life cycle https://www.raps.org/news-and-articles/news-articles/2024/9/who-issues-guideline-to-curb-antibiotic-pollution Regulatory Focus en 2024-09-05 WHO issues guideline to curb antibiotic pollution https://www.raps.org/news-and-articles/news-articles/2024/9/recon-ap-report-claims-fda-faces-backlog-of-2,000 Regulatory Focus en 2024-09-05 Recon: AP report claims FDA faces backlog of 2,000 overdue inspections Lykos CEO steps down after MDMA drug setback https://www.raps.org/news-and-articles/news-articles/2024/9/euro-roundup-mhra-seeks-feedback-on-fee-changes-in Regulatory Focus en 2024-09-05 Euro Roundup: MHRA seeks feedback on fee changes intended to ensure ongoing cost recovery https://www.raps.org/news-and-articles/news-articles/2024/9/fda-revises-final-guidance-on-nitrosamine-impuriti Regulatory Focus en 2024-09-04 FDA revises final guidance on nitrosamine impurities https://www.raps.org/news-and-articles/news-articles/2024/9/study-breakthrough-therapies-approved-based-on-sur Regulatory Focus en 2024-09-04 Study: Breakthrough therapies approved based on surrogate endpoints often lack postmarketing requirements https://www.raps.org/news-and-articles/news-articles/2024/9/stakeholders-ask-for-more-details-in-fda-s-it,-cus Regulatory Focus en 2024-09-03 Stakeholders ask for more details in FDAs IT, customer service strategies https://www.raps.org/news-and-articles/news-articles/2024/9/fda-warns-otc-maker-over-testing-program,-clinical Regulatory Focus en 2024-09-03 FDA warns OTC maker over testing program, clinical investigator for failing to adhere to study plan https://www.raps.org/news-and-articles/news-articles/2024/9/recon-top-eu-court-favors-illumina-over-eu-regulat Regulatory Focus en 2024-09-03 Recon: Top EU court favors Illumina over EU regulators in Grail deal US will still pay more for drugs than its peers after Medicare price negotiations https://www.raps.org/news-and-articles/news-articles/2024/9/asia-pacific-roundup-tga-explains-new-regulations Regulatory Focus en 2024-09-02 Asia-Pacific Roundup: TGA explains new regulations for devices with animal, microbial or recombinant materials https://www.raps.org/news-and-articles/news-articles/2024/8/this-week-at-fda-cder-s-ai-council,-novavax-s-upda Regulatory Focus en 2024-08-30 This Week at FDA: CDERs AI Council, Novavaxs updated COVID vaccine authorized, and more https://www.raps.org/news-and-articles/news-articles/2024/8/fda-sends-warning-letters-to-eye-implant,-bone-mat Regulatory Focus en 2024-08-30 FDA sends warning letters to eye implant, bone matrix manufacturers https://www.raps.org/news-and-articles/news-articles/2024/8/four-companies-warned-for-selling-unauthorized-cpa Regulatory Focus en 2024-08-29 Four companies warned for selling unauthorized CPAP cleaners https://www.raps.org/news-and-articles/news-articles/2024/8/industry-seeks-clarity-on-fda-s-platform-technolog Regulatory Focus en 2024-08-29 Industry seeks clarity on FDAs platform technology designation program https://www.raps.org/news-and-articles/news-articles/2024/8/recon-neurocrine-s-schizophrenia-drug-posts-mixed Regulatory Focus en 2024-08-29 Recon: Neurocrines schizophrenia drug posts mixed results in Phase 2 study BioMarin to lay off 225 of its staff https://www.raps.org/news-and-articles/news-articles/2024/8/euro-roundup-swissmedic-updates-responsible-person Regulatory Focus en 2024-08-29 Euro Roundup: Swissmedic updates responsible person document, asks for immediate action https://www.raps.org/news-and-articles/news-articles/2024/8/fda-officials-resist-calls-to-further-delay-dscsa Regulatory Focus en 2024-08-28 FDA officials resist calls to further delay DSCSA enforcement https://www.raps.org/news-and-articles/news-articles/2024/8/fda-finalizes-malfunction-reporting-requirement-gu Regulatory Focus en 2024-08-28 FDA finalizes malfunction reporting requirement guidance for lower-risk devices to ease burdens https://www.raps.org/news-and-articles/news-articles/2024/8/stakeholders-ask-for-transparency,-agency-rational Regulatory Focus en 2024-08-27 Stakeholders ask for transparency, agency rationale in FDA meeting decisions https://www.raps.org/news-and-articles/news-articles/2024/8/unlocking-opportunities-for-entry-level-positions Regulatory Focus en 2024-08-27 Unlocking opportunities for entry-level positions in regulatory affairs https://www.raps.org/news-and-articles/news-articles/2024/8/latin-america-roundup-mexico-s-top-regulator-to-de Regulatory Focus en 2024-08-27 Latin America Roundup: Mexicos top regulator to depart this fall https://www.raps.org/news-and-articles/news-articles/2024/8/recon-pfizer,-lilly-move-to-sell-drugs-direct-to-c Regulatory Focus en 2024-08-27 Recon: Pfizer, Lilly move to sell drugs direct to consumers Bharat Biotech to launch oral cholera vaccine https://www.raps.org/news-and-articles/news-articles/2024/8/fda-de-novo-requests-must-be-submitted-electronica Regulatory Focus en 2024-08-26 FDA: De novo requests must be submitted electronically beginning October 2025 https://www.raps.org/news-and-articles/news-articles/2024/8/european-commission-proposes-common-specifications Regulatory Focus en 2024-08-26 European Commission proposes common specifications for IVDs for parasites, viruses https://www.raps.org/news-and-articles/news-articles/2024/8/asia-pacific-roundup-medsafe-seeks-feedback-on-cha Regulatory Focus en 2024-08-26 Asia-Pacific Roundup: Medsafe seeks feedback on changes to clinical trial regulation https://www.raps.org/news-and-articles/news-articles/2024/8/recon-siemens-healthineers-seeks-takeover-of-novar Regulatory Focus en 2024-08-26 Recon: Siemens Healthineers seeks takeover of Novartis molecular imaging business FDA expands probe into Lykos MDMA drug studies https://www.raps.org/news-and-articles/news-articles/2024/8/this-week-at-fda-conflict-of-interest-questions-th Regulatory Focus en 2024-08-23 This Week at FDA: Conflict of interest questions threaten to cloud Shurens legacy, FDA signs off on updated COVID vaccines https://www.raps.org/news-and-articles/news-articles/2024/8/ich-adopts-e11a-guideline-to-spur-pediatric-drug-d Regulatory Focus en 2024-08-23 ICH adopts E11A guideline to spur pediatric drug development https://www.raps.org/news-and-articles/news-articles/2024/8/fda-issues-much-anticipated-pccp-draft-guidance Regulatory Focus en 2024-08-22 FDA issues much-anticipated PCCP draft guidance https://www.raps.org/news-and-articles/news-articles/2024/8/gao-udi,-funding-shortfalls-weaken-fda-s-active-su Regulatory Focus en 2024-08-22 GAO: UDI, funding shortfalls weaken FDAs active surveillance program for devices https://www.raps.org/news-and-articles/news-articles/2024/8/fda-s-updated-guidance-on-interchangeable-biosimil Regulatory Focus en 2024-08-22 FDAs updated guidance on interchangeable biosimilars gets mixed response https://www.raps.org/news-and-articles/news-articles/2024/8/recon-fda-authorizes-updated-covid-vaccines;-nice Regulatory Focus en 2024-08-22 Recon: FDA authorizes updated COVID vaccines NICE finds Alzheimers drug Leqembi too pricey for NHS use https://www.raps.org/news-and-articles/news-articles/2024/8/euro-roundup-abpi-calls-for-uk-regulatory-actions Regulatory Focus en 2024-08-22 Euro Roundup: ABPI calls for UK regulatory actions to improve access to cell and gene therapies https://www.raps.org/news-and-articles/news-articles/2024/8/cavazzoni-urges-proactive-measures-to-avoid-crls-f Regulatory Focus en 2024-08-20 Cavazzoni urges proactive measures to avoid CRLs for biologics manufacturing issues https://www.raps.org/news-and-articles/news-articles/2024/8/hda,-nacds-call-on-fda-to-grant-dscsa-reprieve-for Regulatory Focus en 2024-08-20 HDA, NACDS call on FDA to grant DSCSA reprieve for distributors and dispensers https://www.raps.org/news-and-articles/news-articles/2024/8/recon-house-lawmakers-push-fda-to-probe-clinical-s Regulatory Focus en 2024-08-20 Recon: House lawmakers push FDA to probe clinical studies conducted in China JJ to buy V-Wave for up to 17B https://www.raps.org/news-and-articles/news-articles/2024/5/regulatory-strategist-toolbox-free-ai-tools-to-aug Regulatory Focus en 2024-08-20 Regulatory strategist toolbox: Free AI tools to augment deliverables https://www.raps.org/news-and-articles/news-articles/2024/8/stakeholders-disagree-over-how-to-reform-fda-s-adv Regulatory Focus en 2024-08-19 Stakeholders disagree over how to reform FDAs advisory committee system https://www.raps.org/news-and-articles/news-articles/2024/8/fda-finalizes-guidance-on-psg-meetings Regulatory Focus en 2024-08-19 FDA finalizes guidance on PSG meetings https://www.raps.org/news-and-articles/news-articles/2024/8/asia-pacific-roundup-india-waives-local-trial-requ Regulatory Focus en 2024-08-19 Asia-Pacific Roundup: India waives local trial requirements for certain drugs https://www.raps.org/news-and-articles/news-articles/2024/8/recon-fda-lifts-hold-on-biontech-s-cancer-drug-tri Regulatory Focus en 2024-08-19 Recon: FDA lifts hold on BioNTechs cancer drug trial Humana settles Medicare drug overcharging suit for 90M https://www.raps.org/news-and-articles/news-articles/2024/8/dia-and-raps-open-registration-for-2024-regulatory Regulatory Focus en 2024-08-19 DIA and RAPS Open Registration for 2024 Regulatory Policy Forum https://www.raps.org/news-and-articles/news-articles/2024/8/fda-warns-clinical-investigator-for-research-viola Regulatory Focus en 2024-08-16 FDA warns clinical investigator for research violations, device firm over unapproved surgical masks https://www.raps.org/news-and-articles/news-articles/2024/8/this-week-at-fda-fda-approves-first-otc-syphilis-t Regulatory Focus en 2024-08-16 This Week at FDA: FDA approves first OTC syphilis test, final cancer drug dosage guidance, and more https://www.raps.org/news-and-articles/news-articles/2024/8/fda-s-latest-regulatory-agenda-adds-proposed-rules Regulatory Focus en 2024-08-15 FDAs latest regulatory agenda adds proposed rules for pediatric study plans, container closure GMPs https://www.raps.org/news-and-articles/news-articles/2024/8/recon-medicare-unveils-discounted-drug-prices-afte Regulatory Focus en 2024-08-15 Recon: Medicare unveils discounted drug prices after first round of negotiation FDA approves Gileads primary biliary cholangitis drug https://www.raps.org/news-and-articles/news-articles/2024/8/euro-roundup-mhra-shares-guidance-on-planning-appr Regulatory Focus en 2024-08-15 Euro Roundup: MHRA shares guidance on planning approval submissions and seeking support https://www.raps.org/news-and-articles/news-articles/2024/8/ema-updates-guidances-on-treatment,-prophylaxis-fo Regulatory Focus en 2024-08-14 EMA updates guidances on treatment, prophylaxis for chemical and biological agents https://www.raps.org/news-and-articles/news-articles/2024/8/fda-warns-surgical-robot-maker-globus-for-qsr,-mdr Regulatory Focus en 2024-08-14 FDA warns surgical robot maker Globus for QSR, MDR violations https://www.raps.org/news-and-articles/news-articles/2024/8/bimo-inspection-guidance-commenters-question-infor Regulatory Focus en 2024-08-13 BIMO inspection guidance: Commenters question information access requirements https://www.raps.org/news-and-articles/news-articles/2024/8/industry-calls-for-revisions-of-fda-s-rems-draft-g Regulatory Focus en 2024-08-13 Industry calls for revisions of FDAs REMS draft guidance https://www.raps.org/news-and-articles/news-articles/2024/8/latin-america-roundup-cofepris-chief-links-regulat Regulatory Focus en 2024-08-13 Latin America Roundup: COFEPRIS chief links regulatory certainty with contraceptive access https://www.raps.org/news-and-articles/news-articles/2024/8/recon-amgen-sues-samsung-bioepis-over-bone-drug-bi Regulatory Focus en 2024-08-13 Recon: Amgen sues Samsung Bioepis over bone drug biosimilars Carlyle to buy Baxters kidney care unit for 38B https://www.raps.org/news-and-articles/news-articles/2024/8/legal-experts-note-confusion-about-dscsa-waivers Regulatory Focus en 2024-08-12 Legal experts note confusion about DSCSA waivers, exceptions, and exemptions https://www.raps.org/news-and-articles/news-articles/2024/8/stakeholders-ask-for-more-clarity,-risk-based-appr Regulatory Focus en 2024-08-12 Stakeholders ask for more clarity, risk-based approach in CGT, TEMP draft guidance https://www.raps.org/news-and-articles/news-articles/2024/8/fda-updates-bladder-cancer-drug-guidance,-expands Regulatory Focus en 2024-08-12 FDA updates bladder cancer drug guidance, expands single-arm study recommendations https://www.raps.org/news-and-articles/news-articles/2024/8/recon-fda-denies-lykos-mdma-drug;-pfizer-reports-p Regulatory Focus en 2024-08-12 Recon: FDA denies Lykos MDMA drug Pfizer reports positive late-stage results for RSV vaccine in immunocompromised adults https://www.raps.org/news-and-articles/news-articles/2024/8/asia-pacific-roundup-tga-seeks-feedback-on-alignin Regulatory Focus en 2024-08-12 Asia-Pacific Roundup: TGA seeks feedback on aligning Australian essential medtech principles with EU https://www.raps.org/news-and-articles/news-articles/2024/8/this-week-at-fda-fda-announces-slew-of-meetings,-a Regulatory Focus en 2024-08-09 This Week at FDA: FDA announces slew of meetings, approves multiple novel treatments https://www.raps.org/news-and-articles/news-articles/2024/8/fda-finalizes-guidance-on-dose-optimization-studie Regulatory Focus en 2024-08-09 FDA finalizes guidance on dose optimization studies for cancer drugs https://www.raps.org/news-and-articles/news-articles/2024/8/mirati-gets-opdp-untitled-letter-for-misrepresenti Regulatory Focus en 2024-08-08 Mirati gets OPDP untitled letter for misrepresenting cancer drug efficacy https://www.raps.org/news-and-articles/news-articles/2024/8/cdrh-issues-discussion-paper-exploring-health-equi Regulatory Focus en 2024-08-08 CDRH issues discussion paper exploring health equity for medical devices https://www.raps.org/news-and-articles/news-articles/2024/8/euro-roundup-ema-updates-guidelines-on-good-pharma Regulatory Focus en 2024-08-08 Euro Roundup: EMA updates guidelines on good pharmacovigilance practices https://www.raps.org/news-and-articles/news-articles/2024/8/expert-offers-advice-for-developing-successful-cel Regulatory Focus en 2024-08-08 Expert offers advice for developing successful cell and gene therapy product quality system https://www.raps.org/news-and-articles/news-articles/2024/8/recon-recursion-to-buy-exscientia-for-$688m;-fda-a Regulatory Focus en 2024-08-08 Recon: Recursion to buy Exscientia for 688M FDA approves Citius rare blood cancer treatment https://www.raps.org/news-and-articles/news-articles/2024/8/who-consults-on-collaborative-registration-procedu Regulatory Focus en 2024-08-07 WHO consults on collaborative registration procedures guideline https://www.raps.org/news-and-articles/news-articles/2024/7/regulatory-conference-convergence Regulatory Focus en 2024-08-07 16 reasons were excited for RAPS Convergence 2024 https://www.raps.org/news-and-articles/news-articles/2024/8/fda-official-chinese-plastic-syringe-issues-emblem Regulatory Focus en 2024-08-06 FDA official: Chinese plastic syringe issues emblematic of larger manufacturing concerns https://www.raps.org/news-and-articles/news-articles/2024/8/ich-adopts-m13a-guideline-on-bioequivalence-testin Regulatory Focus en 2024-08-06 ICH adopts M13A guideline on bioequivalence testing https://www.raps.org/news-and-articles/news-articles/2024/8/fda-official-data-integrity-is-‘biggest-issue-for Regulatory Focus en 2024-08-06 Data integrity is biggest issue for drug, API firms during inspections, FDA official says https://www.raps.org/news-and-articles/news-articles/2024/8/recon-gsk-prevails-in-illinois-zantac-suit;-baxter Regulatory Focus en 2024-08-06 Recon: GSK prevails in Illinois Zantac suit Baxter lifts forecast on strong device demand https://www.raps.org/news-and-articles/news-articles/2024/8/ema-pilot-aims-to-advise-on-orphan-device-developm Regulatory Focus en 2024-08-05 EMA pilot aims to advise on orphan device development https://www.raps.org/news-and-articles/news-articles/2024/8/fda-official-clarifies-misconceptions-around-rwe-i Regulatory Focus en 2024-08-05 FDA official clarifies misconceptions around RWE in premarket submissions https://www.raps.org/news-and-articles/news-articles/2024/8/experts-explore-strategies-to-improve-fda-s-disclo Regulatory Focus en 2024-08-05 Experts explore strategies to improve FDAs disclosure of confidential commercial info https://www.raps.org/news-and-articles/news-articles/2024/8/asia-pacific-roundup-access-consortium-updates-gen Regulatory Focus en 2024-08-05 Asia-Pacific Roundup: Access Consortium updates generic drug work-sharing procedures https://www.raps.org/news-and-articles/news-articles/2024/8/recon-lawmakers-press-fda-on-lykos-mdma-drug-ahead Regulatory Focus en 2024-08-05 Recon: Lawmakers press FDA on Lykos MDMA drug ahead of PDUFA date FDA approves Adaptimmunes Tecelra for rare cancer https://www.raps.org/news-and-articles/news-articles/2024/8/this-week-at-fda-fda-seeks-new-cdrh-director,-new Regulatory Focus en 2024-08-02 This Week at FDA: FDA seeks new CDRH director, new oncology approvals, ICH M12 adopted https://www.raps.org/news-and-articles/news-articles/2024/8/study-drugs-in-rare-pediatric-disease-priority-rev Regulatory Focus en 2024-08-02 Study: Drugs in rare pediatric disease priority review voucher program have similar revenue to brand drugs https://www.raps.org/news-and-articles/news-articles/2024/8/fda-unveils-fy-2025-user-fee-rates Regulatory Focus en 2024-08-01 FDA unveils FY 2025 user fee rates https://www.raps.org/news-and-articles/news-articles/2024/8/ema-proposes-new-guideline-establishing-therapeuti Regulatory Focus en 2024-08-01 EMA proposes new guideline establishing therapeutic equivalence for nasal products https://www.raps.org/news-and-articles/news-articles/2024/8/euro-roundup-ema-seeks-feedback-on-revised-guideli Regulatory Focus en 2024-08-01 Euro Roundup: EMA seeks feedback on revised guideline on the chemistry of active substances https://www.raps.org/news-and-articles/news-articles/2024/8/recon-sanofi-to-build-new-€1-3b-insulin-plant-in-f Regulatory Focus en 2024-08-01 Recon: Sanofi to build new 13B insulin plant in Frankfurt Novo launches Wegovy in Australia https://www.raps.org/news-and-articles/news-articles/2024/7/regulatory-affairs-trends Regulatory Focus en 2024-07-31 What are the biggest regulatory affairs trends in 2024 https://www.raps.org/news-and-articles/news-articles/2024/7/fda-warns-walmart,-amazon,-and-other-retailers-ove Regulatory Focus en 2024-07-30 FDA warns Walmart, Amazon, and other retailers over unapproved skin peel products https://www.raps.org/news-and-articles/news-articles/2024/7/ema,-gates-foundation-back-pilot-for-african-conti Regulatory Focus en 2024-07-30 EMA, Gates Foundation back pilot for African continental drug evaluations https://www.raps.org/news-and-articles/news-articles/2024/7/latin-america-roundup-cofepris-says-generic-lab-mo Regulatory Focus en 2024-07-30 Latin America Roundup: COFEPRIS says generic lab monopoly lasted two decades, affected access to medicines https://www.raps.org/news-and-articles/news-articles/2024/7/recon-pfizer-raises-profit-forecast-on-cancer,-hea Regulatory Focus en 2024-07-30 Recon: Pfizer raises profit forecast on cancer, heart drug sales amid declining COVID revenue Sanofi sues Sarepta over gene therapy patents https://www.raps.org/news-and-articles/news-articles/2024/7/fda-dings-kaleo-over-instagram-post-with-insuffici Regulatory Focus en 2024-07-29 FDA dings Kaleo over Instagram post with insufficient risk information https://www.raps.org/news-and-articles/news-articles/2024/7/swissmedic-survey-finds-drug-approval-timelines-sl Regulatory Focus en 2024-07-29 Swissmedic survey finds drug approval timelines slower than EMA, FDA https://www.raps.org/news-and-articles/news-articles/2024/7/recon-fda-approves-guardian-s-blood-based-cancer-t Regulatory Focus en 2024-07-29 Recon: FDA approves Guardians blood-based cancer test Boehringer to acquire biotech Nerio for 13B https://www.raps.org/news-and-articles/news-articles/2024/7/asia-pacific-roundup-tga-seeks-feedback-on-bringin Regulatory Focus en 2024-07-29 Asia-Pacific Roundup: TGA seeks feedback on bringing assistive technologies into medtech framework https://www.raps.org/news-and-articles/news-articles/2024/7/regulatory-books-library Regulatory Focus en 2024-07-29 Introducing RAPS Library, a new way to unlock expert regulatory knowledge https://www.raps.org/news-and-articles/news-articles/2024/7/this-week-at-fda-fy2025-budget-roadblock,-biosimil Regulatory Focus en 2024-07-26 This Week at FDA: FY2025 budget roadblock, Biosimilar PSGs, and more https://www.raps.org/news-and-articles/news-articles/2024/7/fda-finalizes-covid-era-guidance-on-container-clos Regulatory Focus en 2024-07-26 FDA finalizes COVID-era guidance on container closure changes https://www.raps.org/news-and-articles/news-articles/2024/7/fda-finalizes-guidance-on-rwd-from-electronic-heal Regulatory Focus en 2024-07-25 FDA finalizes guidance on RWD from electronic health records https://www.raps.org/news-and-articles/news-articles/2024/7/recon-ema-recommends-novo-s-wegovy-for-heart-risks Regulatory Focus en 2024-07-25 Recon: EMA recommends Novos Wegovy for heart risks Mankind to buy Bharat Serums for 16B https://www.raps.org/news-and-articles/news-articles/2024/7/fda-finds-data-integrity,-sterility-problems-at-in Regulatory Focus en 2024-07-25 FDA finds data integrity, sterility problems at Indian drugmaker https://www.raps.org/news-and-articles/news-articles/2024/7/euro-roundup-drugmakers-push-eu-to-strengthen-conf Regulatory Focus en 2024-07-25 Euro Roundup: Drugmakers push EU to strengthen confidentiality protections in HTA proposal https://www.raps.org/news-and-articles/news-articles/2024/7/the-fda-s-quality-management-maturity-program Regulatory Focus en 2024-07-25 The FDAs Quality Management Maturity Program https://www.raps.org/news-and-articles/news-articles/2024/7/raps-announces-board-of-directors-slate-for-2025 Regulatory Focus en 2024-07-25 RAPS announces Board of Directors slate for 2025 https://www.raps.org/news-and-articles/news-articles/2024/7/awards-regulatory-affairs-2024 Regulatory Focus en 2024-07-25 RAPS honors 9 regulatory professionals and one organization with 2024 awards https://www.raps.org/news-and-articles/news-articles/2024/7/shuren-to-leave-fda-after-15-years-as-cdrh-directo Regulatory Focus en 2024-07-23 Shuren to leave FDA after 15 years as CDRH director https://www.raps.org/news-and-articles/news-articles/2024/7/oligonucleotides-ema-drafts-new-guideline-on-manuf Regulatory Focus en 2024-07-23 Oligonucleotides: EMA drafts new guideline on manufacturing and development https://www.raps.org/news-and-articles/news-articles/2024/7/ema-addendum-addresses-vaccine-development-for-imm Regulatory Focus en 2024-07-23 EMA addendum addresses vaccine development for immunocompromised people https://www.raps.org/news-and-articles/news-articles/2024/7/recon-mhra-approves-novo-s-wegovy-for-heart-risks; Regulatory Focus en 2024-07-23 Recon: MHRA approves Novos Wegovy for heart risks Merck says RSV antibody succeeds in Phase 2b3 study https://www.raps.org/news-and-articles/news-articles/2024/7/biosimilars-fda-draft-guidance-addresses-manufactu Regulatory Focus en 2024-07-22 Biosimilars: FDA draft guidance addresses manufacturing changes https://www.raps.org/news-and-articles/news-articles/2024/7/european-commission-president-proposes-new-legisla Regulatory Focus en 2024-07-22 European Commission president proposes new legislation to boost pharma competitiveness https://www.raps.org/news-and-articles/news-articles/2024/7/recon-agilent-to-acquire-biovectra-for-$925m;-chin Regulatory Focus en 2024-07-22 Recon: Agilent to acquire Biovectra for 925M China OKs Eli Lillys tirzepatide for weight loss https://www.raps.org/news-and-articles/news-articles/2024/7/asia-pacific-roundup-india-health-minister-reviews Regulatory Focus en 2024-07-22 Asia-Pacific Roundup: India health minister reviews drug, device regulations in push to raise standards https://www.raps.org/news-and-articles/news-articles/2024/7/this-week-fda-warns-two-chinese-syringe-makers,-ne Regulatory Focus en 2024-07-19 This Week: FDA warns two Chinese syringe makers, new guidances, upcoming meetings https://www.raps.org/news-and-articles/news-articles/2024/7/fda-scolds-chinese-firm-for-data-integrity-lapses Regulatory Focus en 2024-07-19 FDA scolds Chinese firm for data integrity lapses, MIT for BIMO violations https://www.raps.org/news-and-articles/news-articles/2024/7/fda-makes-exception-for-antibody-drug-conjugates-i Regulatory Focus en 2024-07-18 FDA makes exception for antibody drug conjugates in mass balance studies final guidance https://www.raps.org/news-and-articles/news-articles/2024/7/fda-unveils-rare-disease-innovation-hub,-plans-pub Regulatory Focus en 2024-07-18 FDA unveils rare disease innovation hub, plans public meeting this fall https://www.raps.org/news-and-articles/news-articles/2024/7/recon-merck-pushes-dc-federal-court-for-swift-ira Regulatory Focus en 2024-07-18 Recon: Merck pushes DC federal court for swift IRA decision GoodRx unveils discount for Boehringers Humira biosimilar https://www.raps.org/news-and-articles/news-articles/2024/7/euro-roundup-swissmedic-seeks-feedback-on-ich-real Regulatory Focus en 2024-07-18 Euro Roundup: Swissmedic seeks feedback on ICH real-world drug safety data guidance https://www.raps.org/news-and-articles/news-articles/2024/7/raps-fellows-regulatory-affairs-2024 Regulatory Focus en 2024-07-18 These 6 regulatory professionals are the 2024 RAPS Fellows https://www.raps.org/news-and-articles/news-articles/2024/7/fda-guidance-addresses-developing-treatments-for-p Regulatory Focus en 2024-07-17 FDA guidance addresses developing treatments for pediatric IBD https://www.raps.org/news-and-articles/news-articles/2024/7/fda-issues-final-guidance-user-fees-for-combinatio Regulatory Focus en 2024-07-16 FDA issues final guidance user fees for combination products https://www.raps.org/news-and-articles/news-articles/2024/7/cdrh-announces-reorganization,-new-communication-‘ Regulatory Focus en 2024-07-16 CDRH announces reorganization, new communication super office https://www.raps.org/news-and-articles/news-articles/2024/7/latin-america-roundup-mexico-s-cofepris-uncovers-c Regulatory Focus en 2024-07-16 Latin America Roundup: Mexicos COFEPRIS uncovers collusion scheme involving third-party lab https://www.raps.org/news-and-articles/news-articles/2024/7/recon-j-j,-bms-and-astrazeneca-appeal-ira-court-lo Regulatory Focus en 2024-07-16 Recon: JJ, BMS and AstraZeneca appeal IRA court losses Swiss biotech Asceneuron raises 100M to develop Alzheimers drug https://www.raps.org/news-and-articles/news-articles/2024/7/eu-publishes-regulation-governing-use-of-ai-in-med Regulatory Focus en 2024-07-15 EU publishes regulation governing use of AI in medical devices and IVDs https://www.raps.org/news-and-articles/news-articles/2024/7/recon-medicare-pricing-could-thwart-promising-ther Regulatory Focus en 2024-07-15 Recon: Medicare pricing could thwart promising therapies LDT rule could be first to receive scrutiny post-Chevron https://www.raps.org/news-and-articles/news-articles/2024/7/asia-pacific-roundup-philippine-fda-responds-to-fe Regulatory Focus en 2024-07-15 Asia-Pacific Roundup: Philippine FDA responds to feedback on drug and API exports https://www.raps.org/news-and-articles/news-articles/2024/7/this-week-at-fda-new-guidances,-upcoming-meetings Regulatory Focus en 2024-07-12 This Week at FDA: New guidances, upcoming meetings and several recalls https://www.raps.org/news-and-articles/news-articles/2024/7/study-most-drug-products-recouped-development-cost Regulatory Focus en 2024-07-12 Study: Most drug products recouped development costs within a decade of approval https://www.raps.org/news-and-articles/news-articles/2024/7/european-commission-drug-shortage-pilot-study-high Regulatory Focus en 2024-07-11 European Commission drug shortage pilot study highlights industry, regulatory challenges https://www.raps.org/news-and-articles/news-articles/2024/7/recon-fda-rejects-novo-nordisk-s-weekly-insulin;-p Regulatory Focus en 2024-07-11 Recon: FDA rejects Novo Nordisks weekly insulin Pfizer to develop once-daily GLP-1 weight-loss drug https://www.raps.org/news-and-articles/news-articles/2024/7/euro-roundup-eu-updates-mdr,-ivdr-to-add-obligatio Regulatory Focus en 2024-07-11 Euro Roundup: EU updates MDR, IVDR to add obligations for companies facing supply problems https://www.raps.org/news-and-articles/news-articles/2024/7/lab-industry-seeks-more-flexibility-in-fda-emergen Regulatory Focus en 2024-07-10 Lab industry seeks more flexibility in FDA emergency enforcement guidance https://www.raps.org/news-and-articles/news-articles/2024/7/fda-officials-payers-should-be-more-involved-in-ev Regulatory Focus en 2024-07-10 FDA officials: Payers should be more involved in evidence generation https://www.raps.org/news-and-articles/news-articles/2024/7/who-creates-medical-device-database-to-encourage-d Regulatory Focus en 2024-07-09 WHO creates medical device database to encourage data consistency across borders https://www.raps.org/news-and-articles/news-articles/2024/7/recon-ftc-reports-says-pbms-seek-profits-to-detrim Regulatory Focus en 2024-07-09 Recon: FTC reports says PBMs seek profits to detriment of patients and pharmacies Pfizers chief scientist to step down https://www.raps.org/news-and-articles/news-articles/2024/7/industry,-research-push-for-clarity-in-clinical-tr Regulatory Focus en 2024-07-09 Industry, research push for clarity in clinical trial eligibility guidances https://www.raps.org/news-and-articles/news-articles/2024/7/fda-releases-draft-guidance-on-use-related-risk-an Regulatory Focus en 2024-07-09 FDA releases draft guidance on use-related risk analysis for combo products https://www.raps.org/news-and-articles/news-articles/2024/7/new-mdcg-guidance-sets-new-classification-rules-fo Regulatory Focus en 2024-07-08 MDCG guidance sets new classification rules for IVDs https://www.raps.org/news-and-articles/news-articles/2024/7/fda-draft-guidance-aims-to-give-companies-leeway-t Regulatory Focus en 2024-07-08 FDA draft guidance aims to give companies leeway to address medical misinformation https://www.raps.org/news-and-articles/news-articles/2024/7/recon-eli-lilly-to-buy-morphic-for-$3-2-billion;-w Regulatory Focus en 2024-07-08 Recon: Eli Lilly to buy Morphic for 32 billion White House appeals patent decision on HIV preventives https://www.raps.org/news-and-articles/news-articles/2024/7/asia-pacific-roundup-pmda-expands-beyond-japan,-op Regulatory Focus en 2024-07-08 Asia-Pacific Roundup: PMDA expands beyond Japan, opens office in Thailand https://www.raps.org/news-and-articles/news-articles/2024/7/euro-roundup-ema-proposes-updating-psoriatic-arthr Regulatory Focus en 2024-07-04 Euro Roundup: EMA proposes updating psoriatic arthritis trial guidance for first time since 2007 https://www.raps.org/news-and-articles/news-articles/2024/7/fda-tells-another-online-retailer-to-stop-selling Regulatory Focus en 2024-07-03 FDA tells another online retailer to stop selling unapproved popular weight-loss drugs https://www.raps.org/news-and-articles/news-articles/2024/7/ema-proposes-revamping-covid-19-vaccine-guidance-f Regulatory Focus en 2024-07-03 EMA proposes revamping COVID-19 vaccine guidance for the post-pandemic era https://www.raps.org/news-and-articles/news-articles/2024/7/experts-chevron-deference-ruling-will-likely-impac Regulatory Focus en 2024-07-02 Experts: Chevron deference ruling could impact recent FDA regulations https://www.raps.org/news-and-articles/news-articles/2024/7/fda-again-warns-sun-pharma-over-dadra-facility Regulatory Focus en 2024-07-02 FDA again warns Sun Pharma over Dadra facility https://www.raps.org/news-and-articles/news-articles/2024/7/latin-america-roundup-agencies,-paho-hold-meetings Regulatory Focus en 2024-07-02 Latin America Roundup: Agencies, PAHO hold meetings on convergence https://www.raps.org/news-and-articles/news-articles/2024/7/recon-fda-approves-lilly-s-alzheimer-s-drug-kisunl Regulatory Focus en 2024-07-02 Recon: FDA approves Lillys Alzheimers drug Kisunla Biden calls on Novo, Lilly to reduce weight-loss drug prices https://www.raps.org/news-and-articles/news-articles/2024/7/fda-draft-guidance-assists-sponsors-in-measuring-p Regulatory Focus en 2024-07-01 FDA drafts guidance on essential outputs for drug delivery devices https://www.raps.org/news-and-articles/news-articles/2024/7/imdrf-publishes-ai-ml-guiding-principles-echoing-u Regulatory Focus en 2024-07-01 IMDRF publishes AIML guiding principles echoing US, UK, Canadian regulators https://www.raps.org/news-and-articles/news-articles/2024/7/recon-astrazeneca-lines-up-eu-accelerated-assessme Regulatory Focus en 2024-07-01 Recon: AstraZeneca lines up EU accelerated assessment for COVID prevention drug India expert panel urges local approval of Lillys Mounjaro https://www.raps.org/news-and-articles/news-articles/2024/7/asia-pacific-roundup-tga-seeks-feedback-on-planned Regulatory Focus en 2024-07-01 Asia-Pacific Roundup: TGA seeks feedback on planned reform of therapeutic goods testing regulations https://www.raps.org/news-and-articles/news-articles/2024/6/this-week-at-fda-scotus-strikes-down-chevron-defer Regulatory Focus en 2024-06-28 This Week at FDA: SCOTUS strikes down Chevron deference, CDRH partners with Gates Foundation https://www.raps.org/news-and-articles/news-articles/2024/6/expert-industry-needs-‘meticulous-control-over-mas Regulatory Focus en 2024-06-28 Expert: Industry needs meticulous control over master data under DSCSA https://www.raps.org/news-and-articles/news-articles/2024/6/ema-officials-discuss-expedited-approval-pathways, Regulatory Focus en 2024-06-27 EMA officials discuss expedited approval pathways, scientific advice mechanisms https://www.raps.org/news-and-articles/news-articles/2024/6/stakeholders-urge-fda-to-strengthen-guidance-on-bi Regulatory Focus en 2024-06-27 Stakeholders urge FDA to strengthen guidance on biosimilars promotions, stop bad actors https://www.raps.org/news-and-articles/news-articles/2024/6/euro-roundup-ema-posts-guidance-on-declarations-un Regulatory Focus en 2024-06-27 Euro Roundup: EMA posts guidance on declarations under the HTA Regulation https://www.raps.org/news-and-articles/news-articles/2024/6/recon-supreme-court-tosses-purdue-s-bankruptcy-pla Regulatory Focus en 2024-06-27 Recon: Supreme Court tosses Purdues bankruptcy plan FDA rejects Merck, Daiichis lung cancer drug https://www.raps.org/news-and-articles/news-articles/2024/6/fda-issues-diversity-action-plan-draft-guidance Regulatory Focus en 2024-06-26 FDA issues diversity action plan draft guidance https://www.raps.org/news-and-articles/news-articles/2024/6/southern-california-regulatory-networking Regulatory Focus en 2024-06-26 Introducing the RAPS Southern California Local Networking Group https://www.raps.org/news-and-articles/news-articles/2024/6/ema-official-updates-on-eu-clinical-trial-transpar Regulatory Focus en 2024-06-25 EMA official updates on EU clinical trial transparency rules https://www.raps.org/news-and-articles/news-articles/2024/6/mdcg-guidance-tries-to-reduce-burden-of-bringing-o Regulatory Focus en 2024-06-25 MDCG guidance tries to reduce burden of bringing orphan devices to EU market https://www.raps.org/news-and-articles/news-articles/2024/6/recon-fda-rejects-abbvie-parkinson-s-treatment-ove Regulatory Focus en 2024-06-25 Recon: FDA rejects AbbVie Parkinsons treatment over manufacturing concerns AstraZenecas Imfinzi fails in Phase 3 lung cancer trial https://www.raps.org/news-and-articles/news-articles/2024/6/fda-official-tells-cgt-developer-to-leverage-multi Regulatory Focus en 2024-06-24 FDA official tells CGT developers to leverage multiple meeting opportunities with agency https://www.raps.org/news-and-articles/news-articles/2024/6/fda-publishes-ldt-rule-‘cliffsnotes-in-guidance-fo Regulatory Focus en 2024-06-24 FDA publishes LDT rule CliffsNotes in guidance for small companies https://www.raps.org/news-and-articles/news-articles/2024/6/recon-uk-picks-pfizer-to-supply-rsv-vaccine-jabs; Regulatory Focus en 2024-06-24 Recon: UK picks Pfizer to supply RSV vaccine jabs Alnylam touts positive Phase 3 results for heart drug https://www.raps.org/news-and-articles/news-articles/2024/6/asia-pacific-roundup-tga-updates-regulations-on-so Regulatory Focus en 2024-06-24 Asia-Pacific Roundup: TGA updates regulations on software-based medical devices, other medtech products https://www.raps.org/news-and-articles/news-articles/2024/6/industry-officials-report-mixed-experiences-with-r Regulatory Focus en 2024-06-21 Industry officials report mixed experiences with recent FDA pilot programs https://www.raps.org/news-and-articles/news-articles/2024/6/this-week-at-fda-updated-guidance-on-denying-inspe Regulatory Focus en 2024-06-21 This Week at FDA: Updated guidance on denying inspections and biosimilar interchangeability https://www.raps.org/news-and-articles/news-articles/2024/6/stakeholders-request-elaboration,-consistency-in-f Regulatory Focus en 2024-06-21 Stakeholders request elaboration, consistency in FDAs non-interventional RWE studies guidance https://www.raps.org/news-and-articles/news-articles/2024/6/drugmakers,-compounders-at-odds-over-fda-s-difficu Regulatory Focus en 2024-06-20 Drugmakers, compounders at odds over FDAs difficult-to-compound rule https://www.raps.org/news-and-articles/news-articles/2024/6/euro-roundup-commission-publishes-hta-guidance-on Regulatory Focus en 2024-06-20 Euro Roundup: Commission publishes HTA guidance on joint clinical assessments, reporting rules https://www.raps.org/news-and-articles/news-articles/2024/6/dia-marks-questions-the-need-for-new-conditional-a Regulatory Focus en 2024-06-20 DIA: Marks questions the need for new conditional approval pathway https://www.raps.org/news-and-articles/news-articles/2024/6/recon-gilead-s-long-acting-hiv-drug-beats-truvada Regulatory Focus en 2024-06-20 Recon: Gileads long-acting HIV drug beats Truvada in late-stage trial Biocon seeks partner for generic weight loss drugs in China https://www.raps.org/news-and-articles/news-articles/2024/6/dia-pharma-expert-offers-advice-on-ai-best-practic Regulatory Focus en 2024-06-18 DIA: Pharma expert offers advice on AI best practices for industry https://www.raps.org/news-and-articles/news-articles/2024/6/fda-finalizes-guidance-on-drug-development-for-dia Regulatory Focus en 2024-06-18 FDA finalizes guidance on drug development for diabetic foot infections https://www.raps.org/news-and-articles/news-articles/2024/6/recon-fda-approves-merck-s-pneumococcal-jab;-bosto Regulatory Focus en 2024-06-18 Recon: FDA approves Mercks pneumococcal jab Boston Scientific to purchase Silk Road Medical for 116B https://www.raps.org/news-and-articles/news-articles/2024/6/recon-vaping-as-good-as-drug-for-smoking-cessation Regulatory Focus en 2024-06-17 Recon: Vaping as good as drug for smoking cessation FTC scrubbing Orange Book of device patents https://www.raps.org/news-and-articles/news-articles/2024/6/fda-finalizes-guidance-giving-anda-facilities-time Regulatory Focus en 2024-06-17 FDA finalizes guidance giving ANDA facilities time to comply with cGMP https://www.raps.org/news-and-articles/news-articles/2024/6/study-women-underrepresented-in-clinical-trials-of Regulatory Focus en 2024-06-17 Study: Women underrepresented in clinical trials of medical devices https://www.raps.org/news-and-articles/news-articles/2024/6/asia-pacific-roundup-australia-s-tga-sets-out-tran Regulatory Focus en 2024-06-17 Asia-Pacific Roundup: Australias TGA sets out transition to newer version of PICS Guide to GMP https://www.raps.org/news-and-articles/news-articles/2024/6/this-week-at-fda-scotus-throws-out-mifepristone-ca Regulatory Focus en 2024-06-14 This Week at FDA: SCOTUS throws out mifepristone case, House subcommittee passes FDA budget https://www.raps.org/news-and-articles/news-articles/2024/6/raps-board-regulatory-affairs Regulatory Focus en 2024-06-14 These RAPS members have been selected to join our Board of Directors in 2025 https://www.raps.org/news-and-articles/news-articles/2024/6/fda,-health-canada,-mhra-release-guiding-principle Regulatory Focus en 2024-06-14 FDA, Health Canada, MHRA release guiding principles on transparency for machine learning medical devices https://www.raps.org/news-and-articles/news-articles/2024/6/fda-grants-small-dispensers-two-year-delay-for-dsc Regulatory Focus en 2024-06-13 FDA grants small dispensers two-year delay for DSCSA tracking rules, opens door for exemption requests https://www.raps.org/news-and-articles/news-articles/2024/6/mdcg-aims-to-harmonize-adverse-events-reports-for Regulatory Focus en 2024-06-13 MDCG aims to harmonize adverse events reports for surgical mesh in the EU https://www.raps.org/news-and-articles/news-articles/2024/6/euro-roundup-switzerland-updates-legislation-to-im Regulatory Focus en 2024-06-13 Euro Roundup: Switzerland updates legislation to improve clinical trial framework https://www.raps.org/news-and-articles/news-articles/2024/6/recon-supreme-court-rejects-lawsuit-challenging-ab Regulatory Focus en 2024-06-13 Recon: Supreme Court rejects lawsuit challenging abortion pill deliveries Pfizers Duchenne muscular dystrophy gene therapy falters in late-stage study https://www.raps.org/news-and-articles/news-articles/2024/6/ich-announces-forthcoming-documents-on-nitrosamine Regulatory Focus en 2024-06-12 ICH announces forthcoming documents on nitrosamine impurities, RWD https://www.raps.org/news-and-articles/news-articles/2024/6/house-lawmakers-spar-over-proposed-fda-fy-2025-bud Regulatory Focus en 2024-06-11 House lawmakers spar over proposed FDA FY 2025 budget https://www.raps.org/news-and-articles/news-articles/2024/6/latin-america-roundup-brazil-s-clinical-trials-law Regulatory Focus en 2024-06-11 Latin America Roundup: Brazils clinical trials law strengthens participant protections https://www.raps.org/news-and-articles/news-articles/2024/6/expert-manufacturers-making-‘great-progress-toward Regulatory Focus en 2024-06-11 Expert: Manufacturers making great progress towards DSCSA compliance https://www.raps.org/news-and-articles/news-articles/2024/6/recon-fda-advisory-panel-endorses-lilly-s-alzheime Regulatory Focus en 2024-06-11 Recon: FDA advisory panel endorses Lillys Alzheimers therapy Genfit, Ipsen get accelerated approval for liver disease drug https://www.raps.org/news-and-articles/news-articles/2024/6/experts-advise-against-prescriptive-fda-policies-f Regulatory Focus en 2024-06-10 Experts advise against prescriptive FDA policies for regulating AI https://www.raps.org/news-and-articles/news-articles/2024/6/regulators-launch-two-act-eu-advice-pilots-to-prom Regulatory Focus en 2024-06-10 Regulators launch two ACT EU advice pilots to promote clinical research in Europe https://www.raps.org/news-and-articles/news-articles/2024/6/asia-pacific-roundup-hong-kong-advances-new-centre Regulatory Focus en 2024-06-10 Asia-Pacific Roundup: Hong Kong advances new Centre for Medical Products Regulation https://www.raps.org/news-and-articles/news-articles/2024/6/recon-fda-oks-geron-s-anemia-therapy-for-specific Regulatory Focus en 2024-06-10 Recon: FDA OKs Gerons anemia therapy for specific cancer patients Moderna reports positive Phase 3 results for COVIDflu combo https://www.raps.org/news-and-articles/news-articles/2024/6/regulatory-intelligence-conference-raps-2024 Regulatory Focus en 2024-06-07 How 100 professionals learned about regulatory intelligence at the RAPS Regulatory Intelligence Conference 2024 https://www.raps.org/news-and-articles/news-articles/2024/6/this-week-at-fda-lawmakers-ask-about-cures-2-0,-ca Regulatory Focus en 2024-06-07 This Week at FDA: Lawmakers ask about CURES 20, Califf wants more pragmatic clinical research https://www.raps.org/news-and-articles/news-articles/2024/6/industry-experts-peel-back-the-curtain-on-user-fee Regulatory Focus en 2024-06-07 Industry experts peel back the curtain on user fee negotiations https://www.raps.org/news-and-articles/news-articles/2024/6/rf-quarterly,-june-2024-quality-in-the-regulatory Regulatory Focus en 2024-06-07 RF Quarterly, June 2024: Quality in the regulatory setting https://www.raps.org/news-and-articles/news-articles/2024/6/quality-considerations-for-cellular-and-gene-thera Regulatory Focus en 2024-06-07 Product quality considerations for cellular and gene therapy products https://www.raps.org/news-and-articles/news-articles/2024/6/quality-considerations-for-generic-drugs-entering Regulatory Focus en 2024-06-07 Quality considerations for generic drugs entering the Chinese market https://www.raps.org/news-and-articles/news-articles/2024/6/pragmatic-implementation-of-an-efficient-and-effec Regulatory Focus en 2024-06-07 Pragmatic implementation of an efficient and effective QMS https://www.raps.org/news-and-articles/news-articles/2024/6/pharmaceutical-stability-testing,-part-1- an-overv Regulatory Focus en 2024-06-07 Pharmaceutical stability testing, Part 1:An overview of stability https://www.raps.org/news-and-articles/news-articles/2024/6/pharmaceutical-stability-testing,-part-2-stability Regulatory Focus en 2024-06-07 Pharmaceutical stability testing, Part 2: Stability stress testing https://www.raps.org/news-and-articles/news-articles/2024/6/pharmaceutical-stability-testing,-part-3-bracketin Regulatory Focus en 2024-06-07 Pharmaceutical stability testing, Part 3: Bracketing and matrixing designs https://www.raps.org/news-and-articles/news-articles/2024/6/aam,-bms-ask-fda-to-acknowledge-role-of-third-part Regulatory Focus en 2024-06-06 AAM, BMS ask FDA to acknowledge role of third parties in BABE studies https://www.raps.org/news-and-articles/news-articles/2024/6/fda-official-offers-compliance-updates,-discusses Regulatory Focus en 2024-06-06 FDA official offers compliance updates, discusses enforcement misperceptions https://www.raps.org/news-and-articles/news-articles/2024/6/euro-roundup-swissmedic-revises-four-medicines-aut Regulatory Focus en 2024-06-06 Euro Roundup: Swissmedic revises four medicines authorization guidances https://www.raps.org/news-and-articles/news-articles/2024/6/recon-novartis,-roche-face-italian-antitrust-probe Regulatory Focus en 2024-06-06 Recon: Novartis, Roche face Italian antitrust probe, Novo braces for generic Ozempic in China https://www.raps.org/news-and-articles/news-articles/2024/6/fda-issues-draft-guidances-covering-bimo-inspectio Regulatory Focus en 2024-06-05 FDA issues draft guidances covering BIMO inspections https://www.raps.org/news-and-articles/news-articles/2024/6/cdrh-lab-chief-encourages-stakeholders-to-pitch-re Regulatory Focus en 2024-06-04 CDRH lab chief encourages stakeholders to suggest regulatory science tools https://www.raps.org/news-and-articles/news-articles/2024/6/fda-official-discusses-best-practice-for-requestin Regulatory Focus en 2024-06-04 FDA official discusses best practice for requesting feedback for combination products https://www.raps.org/news-and-articles/news-articles/2024/6/recon-fda-panel-weighs-mdma-drug-for-ptsd;-annexon Regulatory Focus en 2024-06-04 Recon: FDA panel weighs MDMA drug for PTSD Annexon says GBS drug succeeds in Phase 3 trial https://www.raps.org/news-and-articles/news-articles/2024/6/aam-seeks-clarity,-leeway-in-ba-be-studies-guidanc Regulatory Focus en 2024-06-03 AAM seeks clarity, leeway in BABE studies guidance https://www.raps.org/news-and-articles/news-articles/2024/6/experts,-fda-officials-discuss-future-of-clinical Regulatory Focus en 2024-06-03 Experts, FDA officials discuss future of clinical trials https://www.raps.org/news-and-articles/news-articles/2024/6/asia-pacific-roundup-india-revises-pharmacovigilan Regulatory Focus en 2024-06-03 Asia-Pacific Roundup: India revises pharmacovigilance guidance for vaccines https://www.raps.org/news-and-articles/news-articles/2024/6/recon-delaware-judge-allows-70,000-zantac-lawsuits Regulatory Focus en 2024-06-03 Recon: Delaware judge allows 70,000 Zantac lawsuits to proceed BD to buy Edwards critical care unit for 42B https://www.raps.org/news-and-articles/news-articles/2024/5/fda-official-offers-updates-on-c3ti,-knowledge-rep Regulatory Focus en 2024-05-31 FDA official offers updates on C3TI, knowledge repository https://www.raps.org/news-and-articles/news-articles/2024/5/this-week-fda-cleared-for-major-reorg,-acla-sues-o Regulatory Focus en 2024-05-31 This Week at FDA: FDA cleared for major reorg, ACLA sues over LDT rule https://www.raps.org/news-and-articles/news-articles/2024/5/fda-plans-to-release-ai-drug-development-guidance Regulatory Focus en 2024-05-30 FDA plans to release AI drug development guidance this year https://www.raps.org/news-and-articles/news-articles/2024/5/eu-council-adopts-amendments-delaying-ivdr-deadlin Regulatory Focus en 2024-05-30 EU Council adopts amendments delaying IVDR deadlines https://www.raps.org/news-and-articles/news-articles/2024/5/euro-roundup-european-commission-greenlights-med4c Regulatory Focus en 2024-05-30 Euro Roundup: European Commission greenlights Med4Cure project https://www.raps.org/news-and-articles/news-articles/2024/5/fda-reorganization-greenlit,-slated-to-begin-in-oc Regulatory Focus en 2024-05-30 FDA reorganization greenlit, slated to begin in October https://www.raps.org/news-and-articles/news-articles/2024/5/recon-clinical-labs-trade-group-sues-to-block-fda Regulatory Focus en 2024-05-30 Recon: Clinical labs trade group sues to block FDAs LDT rule FDA expands use of BMS blood cancer drug Breyanzi https://www.raps.org/news-and-articles/news-articles/2024/5/european-commission-adopts-rules-for-joint-clinica Regulatory Focus en 2024-05-29 European Commission adopts rules for joint clinical assessments https://www.raps.org/news-and-articles/news-articles/2022/5/fda-issues-platform-technology-designation-draft-g Regulatory Focus en 2024-05-28 FDA issues platform technology designation draft guidance https://www.raps.org/news-and-articles/news-articles/2024/5/ich-adopts-m12-guideline-on-drug-interaction-studi Regulatory Focus en 2024-05-28 ICH adopts M12 guideline on drug interaction studies, releases draft M14 guidance on RWD https://www.raps.org/news-and-articles/news-articles/2024/5/latin-america-roundup-chile-names-new-top-regulato Regulatory Focus en 2024-05-28 Latin America Roundup: Chile releases new internationally aligned clinical trials guidance https://www.raps.org/news-and-articles/news-articles/2024/5/recon-j-j-buys-experimental-eczema-drug-from-numab Regulatory Focus en 2024-05-28 Recon: JJ buys experimental eczema drug from Numab for 125B Asahi Kasei to acquire Calliditas in 11B deal https://www.raps.org/news-and-articles/news-articles/2024/5/this-week-at-fda-multiple-adcomms,-louisiana-lawma Regulatory Focus en 2024-05-24 This Week at FDA: Multiple adcomms, Louisiana lawmakers crack down on medication abortion https://www.raps.org/news-and-articles/news-articles/2024/5/experts,-lawmakers-express-support-for-select-drug Regulatory Focus en 2024-05-24 Experts, lawmakers express support for select drug patent reforms https://www.raps.org/news-and-articles/news-articles/2024/5/rac-regulatory-affairs-certification-spring-2024 Regulatory Focus en 2024-05-24 These 108 professionals earned their RAC credentials in spring 2024 https://www.raps.org/news-and-articles/news-articles/2024/5/rcc-regulatory-compliance-certifications-list Regulatory Focus en 2024-05-24 These 39 professionals earned their RCC credentials in spring 2024 https://www.raps.org/news-and-articles/news-articles/2024/5/fda-new-logic-model-sets-structured-approach-to-re Regulatory Focus en 2024-05-23 FDA: New logic model sets structured approach to REMS development https://www.raps.org/news-and-articles/news-articles/2024/5/stakeholders-want-more-early-fda-communication-opt Regulatory Focus en 2024-05-23 Stakeholders want more early FDA communication options, shorter Q-Sub response timelines https://www.raps.org/news-and-articles/news-articles/2024/5/euro-roundup-european-medicines-network-joins-who Regulatory Focus en 2024-05-23 Euro Roundup: European medicines network joins WHO listed authority program https://www.raps.org/news-and-articles/news-articles/2024/5/recon-pfizer-looks-to-cut-$1-5b-in-spending-by-202 Regulatory Focus en 2024-05-23 Recon: Pfizer looks to cut 15B in spending by 2027 Drugmakers prevail in first Zantac cancer trial https://www.raps.org/news-and-articles/news-articles/2024/5/mhra-proposes-requirements-for-high-risk-ivds Regulatory Focus en 2024-05-22 MHRA proposes requirements for high-risk IVDs https://www.raps.org/news-and-articles/news-articles/2024/5/mhra-proposes-recognition-path-for-devices-cleared Regulatory Focus en 2024-05-21 MHRA proposes recognition path for devices cleared by trusted regulators https://www.raps.org/news-and-articles/news-articles/2024/5/ema-revises-q-a-guidance-on-drug-device-combinatio Regulatory Focus en 2024-05-21 EMA revises QA guidance on drug-device combination products https://www.raps.org/news-and-articles/news-articles/2024/5/notified-bodies-concerned-with-dearth-of-mdr-ivdr Regulatory Focus en 2024-05-21 Notified bodies concerned with lack of MDRIVDR applications as deadlines approach https://www.raps.org/news-and-articles/news-articles/2024/5/recon-fda-staff-find-guardant-test-may-not-identif Regulatory Focus en 2024-05-21 Recon: FDA staff find Guardant test may not identify certain pre-cancerous tumors AstraZeneca targets 80B in revenue and 20 new therapies by 2030 https://www.raps.org/news-and-articles/news-articles/2024/5/fda-concerned-about-potential-device-shortage-due Regulatory Focus en 2024-05-20 FDA concerned about potential device shortages due to new EtO limits https://www.raps.org/news-and-articles/news-articles/2024/5/survey-trust-in-fda-varies-by-group Regulatory Focus en 2024-05-20 Survey: Trust in FDA varies by group https://www.raps.org/news-and-articles/news-articles/2024/5/asia-pacific-roundup-philippine-fda-consults-on-ch Regulatory Focus en 2024-05-20 Asia-Pacific Roundup: Philippine FDA consults on changes to drug product and API rules https://www.raps.org/news-and-articles/news-articles/2024/5/recon-fda-approves-first-two-biosimilars-to-regene Regulatory Focus en 2024-05-20 Recon: FDA approves first two biosimilars to Regenerons Eylea Neuralink cleared to implant brain chip in second patient https://www.raps.org/news-and-articles/news-articles/2024/5/this-week-at-fda-lawmakers-promote-research-bills, Regulatory Focus en 2024-05-17 This Week at FDA: Lawmakers promote research bills, Biden works to reschedule marijuana, upcoming FDA meetings https://www.raps.org/news-and-articles/news-articles/2024/5/stakeholders-provide-feedback-on-fda-draft-guidanc Regulatory Focus en 2024-05-17 Stakeholders provide feedback on FDA draft guidance on drug development for early Alzheimers disease https://www.raps.org/news-and-articles/news-articles/2024/5/cavazzoni-no-more-‘kicking-the-can-down-the-road-f Regulatory Focus en 2024-05-16 Cavazzoni: No more kicking the can down the road for DSCSA compliance https://www.raps.org/news-and-articles/news-articles/2024/5/recon-lilly-s-weekly-insulin-found-comparable-to-d Regulatory Focus en 2024-05-16 Recon: Lillys weekly insulin found comparable to daily products Biogen, Ionis end ALS drug program after early-stage miss https://www.raps.org/news-and-articles/news-articles/2024/5/euro-roundup-mhra-launches-ai-airlock Regulatory Focus en 2024-05-16 Euro Roundup: MHRA launches AI Airlock https://www.raps.org/news-and-articles/news-articles/2024/5/stakeholders-requests-tweaks-to-fda-s-device-cyber Regulatory Focus en 2024-05-15 Stakeholders request tweaks to FDAs device cybersecurity guidance https://www.raps.org/news-and-articles/news-articles/2024/5/euro-convergence-experts-discuss-supply-chain-chal Regulatory Focus en 2024-05-15 Euro Convergence: Experts discuss supply chain challenges, potential solutions https://www.raps.org/news-and-articles/news-articles/2024/5/euro-convergence-experts-concerned-about-incompati Regulatory Focus en 2024-05-14 Euro Convergence: Experts concerned about incompatibilities between AI Act and MDR https://www.raps.org/news-and-articles/news-articles/2024/5/recon-fda-delays-decision-on-ascendis-hormone-diso Regulatory Focus en 2024-05-14 Recon: FDA delays decision on Ascendis hormone disorder drug Edwards faces EU antitrust complaint https://www.raps.org/news-and-articles/news-articles/2024/5/eu-report-examines-barriers-to-combined-studies-of Regulatory Focus en 2024-05-14 EU report examines barriers to combined studies of drugs, IVDs, and devices https://www.raps.org/news-and-articles/news-articles/2024/5/latin-america-roundup-mexico,-paho-seek-to-help-gu Regulatory Focus en 2024-05-14 Latin America Roundup: Mexico, PAHO seek to help Guatemala boost regulatory capacity https://www.raps.org/news-and-articles/news-articles/2024/5/rcc-regulatory-compliance-certification-exam-info Regulatory Focus en 2024-05-14 4 things the first-ever RCC credential holders want you to know https://www.raps.org/news-and-articles/news-articles/2024/5/groups-tell-congress-fda-does-not-need-a-new-regul Regulatory Focus en 2024-05-13 Groups tell Congress FDA does not need a new regulatory framework for AI devices https://www.raps.org/news-and-articles/news-articles/2024/5/euro-convergence-stakeholders-seek-more-product-sp Regulatory Focus en 2024-05-13 Euro Convergence: Stakeholders seek more product-specific, technical dossier-related guidance https://www.raps.org/news-and-articles/news-articles/2024/5/asia-pacific-roundup-malaysia-s-npra-to-start-1-ye Regulatory Focus en 2024-05-13 Asia-Pacific Roundup: Malaysias NPRA to start 1-year pilot of new variation application timelines https://www.raps.org/news-and-articles/news-articles/2024/5/recon-sanofi-eyes-$1-1b-investment-in-french-manuf Regulatory Focus en 2024-05-13 Recon: Sanofi eyes 11B investment in French manufacturing sites Shionogi COVID treatment misses endpoint in Phase 3 trial https://www.raps.org/news-and-articles/news-articles/2024/5/this-week-at-fda-califf-faces-senate-appropriation Regulatory Focus en 2024-05-10 This Week at FDA: Califf faces Senate Appropriations hearing, interagency biotech plan, and remanufacturing guidance https://www.raps.org/news-and-articles/news-articles/2024/5/fda-issues-long-awaited-device-remanufacturing-gui Regulatory Focus en 2024-05-10 FDA issues long-awaited device remanufacturing guidance https://www.raps.org/news-and-articles/news-articles/2024/5/top-fda-officials-discuss-pdufa-hiring,-rapid-comm Regulatory Focus en 2024-05-09 Top FDA officials discuss PDUFA hiring, rapid communication, and international collaboration efforts https://www.raps.org/news-and-articles/news-articles/2024/5/euro-roundup-ema-shares-draft-paper-on-non-interve Regulatory Focus en 2024-05-09 Euro Roundup: EMA shares draft paper on non-interventional studies using RWD https://www.raps.org/news-and-articles/news-articles/2024/5/recon-merck-s-endometrial-cancer-treatment-falters Regulatory Focus en 2024-05-09 Recon: Mercks endometrial cancer treatment falters in study Novo signs 600M deal with Metaphore to develop new obesity drugs https://www.raps.org/news-and-articles/news-articles/2024/5/califf-grilled-on-avian-flu,-drug-shortages,-and-a Regulatory Focus en 2024-05-08 Califf grilled on avian flu, drug shortages, and adcomms during Senate Appropriations hearing https://www.raps.org/news-and-articles/news-articles/2024/5/euro-convergence-regulators-discuss-device-availab Regulatory Focus en 2024-05-08 Euro Convergence: Regulators discuss device availability, AI Act, lessons from pharma https://www.raps.org/news-and-articles/news-articles/2024/5/euro-convergence-conference-regulatory-affairs Regulatory Focus en 2024-05-08 Highlights from RAPS Euro Convergence 2024, another record-breaking event for RAPS in Europe https://www.raps.org/news-and-articles/news-articles/2024/5/cavazzoni-fda-wants-to-prevent-manufacturing-stopp Regulatory Focus en 2024-05-07 Cavazzoni: FDA wants to prevent manufacturing stoppages during inspections https://www.raps.org/news-and-articles/news-articles/2024/5/recon-fda-schedules-june-adcomm-to-review-lilly-al Regulatory Focus en 2024-05-07 Recon: FDA schedules June adcomm to review Lilly Alzheimers drug Medtronic cleared to sell renal denervation device in China https://www.raps.org/news-and-articles/news-articles/2024/5/euro-convergence-experts-seek-‘future-proof-pharma Regulatory Focus en 2024-05-07 Euro Convergence: Experts seek future proof pharma legislation as EU elections nears https://www.raps.org/news-and-articles/news-articles/2024/5/stakeholders-welcome-fda-s-informed-consent-‘key-i Regulatory Focus en 2024-05-06 Stakeholders welcome FDAs informed consent key information guidance https://www.raps.org/news-and-articles/news-articles/2024/5/fda-unveils-draft-guidance-on-rems-logic-models Regulatory Focus en 2024-05-06 FDA unveils draft guidance on REMS logic models https://www.raps.org/news-and-articles/news-articles/2024/5/euro-convergence-experts-agree-regulatory-affairs Regulatory Focus en 2024-05-06 Euro Convergence: Experts agree regulatory affairs is both science and art https://www.raps.org/news-and-articles/news-articles/2024/5/recon-j-j-touts-‘pretzel-drug-device-combo-results Regulatory Focus en 2024-05-06 Recon: JJ touts pretzel drug-device combo results for bladder cancer FDA hands Zydus another Form 483 over facility deficiencies https://www.raps.org/news-and-articles/news-articles/2024/5/asia-pacific-roundup-philippine-fda-seeks-feedback Regulatory Focus en 2024-05-06 Asia-Pacific Roundup: Philippine FDA seeks feedback on clinical trial inspection deficiencies https://www.raps.org/news-and-articles/news-articles/2024/5/fda-exploring-model-master-files-to-expedite-gener Regulatory Focus en 2024-05-03 FDA exploring model master files to expedite generic drug development https://www.raps.org/news-and-articles/news-articles/2024/5/this-week-at-fda-adcomm-reforms,-ftc-warning-lette Regulatory Focus en 2024-05-03 This Week at FDA: AdComm reforms, FTC warning letters, and marijuana rescheduling https://www.raps.org/news-and-articles/news-articles/2024/5/euro-convergence-2024-offers-broad-program,-from-a Regulatory Focus en 2024-05-03 Euro Convergence 2024: From AI to supply chain management https://www.raps.org/news-and-articles/news-articles/2024/5/medcon-consider-a-master-validation-plan-for-proce Regulatory Focus en 2024-05-02 FDA officials: Consider a master validation plan for process validation during inspections https://www.raps.org/news-and-articles/news-articles/2024/5/ora-chief-says-funding-needed-to-keep-pace-with-gr Regulatory Focus en 2024-05-02 ORA chief says funding needed to keep pace with growing inspectional inventory https://www.raps.org/news-and-articles/news-articles/2024/5/stakeholders-push-for-greater-inclusion-in-fda-s-r Regulatory Focus en 2024-05-02 Stakeholders push for greater inclusion in FDAs race and ethnicity data collection guidance https://www.raps.org/news-and-articles/news-articles/2024/5/recon-novartis-set-to-purchase-mariana-for-$1b;-fd Regulatory Focus en 2024-05-02 Recon: Novartis set to purchase Mariana for 1B FDA requests more data on Dupixent for COPD https://www.raps.org/news-and-articles/news-articles/2024/5/euro-roundup-mhra-outlines-potential-impact-of-ai Regulatory Focus en 2024-05-02 Euro Roundup: MHRA outlines potential impact of AI on medical products regulation https://www.raps.org/news-and-articles/news-articles/2024/5/who-recommends-risk-management-plans-for-high-risk Regulatory Focus en 2024-05-01 WHO recommends risk management plans for high-risk excipients https://www.raps.org/news-and-articles/news-articles/2024/5/device-experts-offer-tips-on-handling-warning-lett Regulatory Focus en 2024-05-01 Device experts offer tips on handling warning letter, 483 responses https://www.raps.org/news-and-articles/news-articles/2024/4/fda-drafts-two-guidances-on-safety-testing-for-cel Regulatory Focus en 2024-04-30 FDA drafts two guidances on safety testing for cell and gene therapy products https://www.raps.org/news-and-articles/news-articles/2024/4/latin-america-roundup-panama-adopts-international Regulatory Focus en 2024-04-30 Latin America Roundup: Panama adopts international pharmacovigilance standards https://www.raps.org/news-and-articles/news-articles/2024/4/medcon-fda-readies-staff,-device-makers-for-qmsr Regulatory Focus en 2024-04-30 MedCon: FDA readies staff, device makers for QMSR https://www.raps.org/news-and-articles/news-articles/2024/4/recon-ftc-warns-drugmakers-over-‘junk-orange-book Regulatory Focus en 2024-04-30 Recon: FTC warns drugmakers over junk Orange Book patents FDA solicits public feedback on advisory committee reforms https://www.raps.org/news-and-articles/news-articles/2024/4/emerging-technologies-and-regulatory-agency-guidan Regulatory Focus en 2024-04-30 Emerging technologies and regulatory agency guidance for CGTs https://www.raps.org/news-and-articles/news-articles/2024/4/regulatory-affairs-jobs-stats Regulatory Focus en 2024-04-30 New Report Showcases a Global Regulatory Affairs Workforce of Nearly 125,000 Professionals Across the Healthcare Products Sector https://www.raps.org/news-and-articles/news-articles/2024/4/fda-issues-three-guidances-to-expand-cancer-clinic Regulatory Focus en 2024-04-29 FDA issues three guidances to expand cancer clinical trial eligibility https://www.raps.org/news-and-articles/news-articles/2024/4/medcon-crdh-official-offers-tips-for-electronic-su Regulatory Focus en 2024-04-29 MedCon: CRDH official offers tips for electronic submissions, eSTAR technical screening https://www.raps.org/news-and-articles/news-articles/2024/4/fda-issues-long-awaited-ldt-final-rule Regulatory Focus en 2024-04-29 FDA issues long-awaited LDT final rule https://www.raps.org/news-and-articles/news-articles/2024/4/recon-ono-set-to-buy-deciphera-for-$2-4b;-fda-appr Regulatory Focus en 2024-04-29 Recon: Ono set to buy Deciphera for 24B FDA approves X4s ultra-rare immunodeficiency disease therapy https://www.raps.org/news-and-articles/news-articles/2024/4/asia-pacific-roundup-philippine-fda-seeks-feedback Regulatory Focus en 2024-04-29 Asia-Pacific Roundup: Philippine FDA seeks feedback on import and export notifications https://www.raps.org/news-and-articles/news-articles/2024/4/this-week-at-fda-fda-s-final-ldt-rule-nears,-cardi Regulatory Focus en 2024-04-26 This Week at FDA: FDAs final LDT rule nears, Cardinal Health warning letter, and more https://www.raps.org/news-and-articles/news-articles/2024/4/fda-updates-guidance-on-promotional-labeling-and-a Regulatory Focus en 2024-04-26 FDA updates guidance on promotional labeling and advertising of biosimilars https://www.raps.org/news-and-articles/news-articles/2024/4/300-global-regulators-and-industry-partners-gather Regulatory Focus en 2024-04-26 300 Global Regulators and Industry Partners Gather in Columbus for MedCon 2024 https://www.raps.org/news-and-articles/news-articles/2024/4/fda-provides-update-on-status-of-postmarketing-rep Regulatory Focus en 2024-04-25 FDA provides update on status of postmarketing reports and commitments https://www.raps.org/news-and-articles/news-articles/2024/4/euro-roundup-parliament-approves-creation-of-a-eur Regulatory Focus en 2024-04-25 Euro Roundup: Parliament approves creation of a European Health Data Space https://www.raps.org/news-and-articles/news-articles/2024/4/european-parliament-votes-to-delay-ivdr-transition Regulatory Focus en 2024-04-25 European Parliament votes to delay IVDR transition, speed EUDAMED adoption https://www.raps.org/news-and-articles/news-articles/2024/4/medcon-ora-official-discusses-class-i-recalls,-rra Regulatory Focus en 2024-04-25 MedCon: ORA official discusses Class I recalls, RRA, QMSR, reorganization https://www.raps.org/news-and-articles/news-articles/2024/4/recon-senate-committee-probes-novo-s-ozempic-and-w Regulatory Focus en 2024-04-25 Recon: Senate committee probes Novos Ozempic and Wegovy pricing GSK sues Pfizer, BioNTech over COVID vaccine tech https://www.raps.org/news-and-articles/news-articles/2024/4/cber-chief-on-remote-work,-crispr-cas9,-and-rare-d Regulatory Focus en 2024-04-24 CBER chief on remote work, CRISPR-Cas9, and rare disease gene therapy accelerated approval guidance https://www.raps.org/news-and-articles/news-articles/2024/4/medcon-shuren-updates-on-mdufa-v,-tap,-health-equi Regulatory Focus en 2024-04-24 MedCon: Shuren updates on MDUFA V, TAP, health equity https://www.raps.org/news-and-articles/news-articles/2024/4/fda-warns-philips-about-imaging-device-violations Regulatory Focus en 2024-04-24 FDA warns Philips about imaging device violations at China facility https://www.raps.org/news-and-articles/news-articles/2024/4/expert-mhra-expected-to-launch-recognition-framewo Regulatory Focus en 2024-04-24 Expert: MHRA expected to launch recognition framework for devices https://www.raps.org/news-and-articles/news-articles/2024/4/eu-group-calls-for-multi-prong-measures-to-tackle Regulatory Focus en 2024-04-23 EMA group calls for multi-prong measures to tackle shortages https://www.raps.org/news-and-articles/news-articles/2024/4/industry-advises-practical-fixes-for-new-fda-guida Regulatory Focus en 2024-04-23 Industry advises practical fixes for new FDA guidance on data monitoring committees https://www.raps.org/news-and-articles/news-articles/2024/4/recon-fda-approves-immunitybio-bladder-cancer-trea Regulatory Focus en 2024-04-23 Recon: FDA approves ImmunityBio bladder cancer treatment Lawsuit alleges Novartis promoted asthma drug for preterm labor despite brain risk https://www.raps.org/news-and-articles/news-articles/2024/4/rac-regulatory-affairs-certification-drugs-devices Regulatory Focus en 2024-04-23 Is the Regulatory Affairs Certification right for you An in-depth guide https://www.raps.org/news-and-articles/news-articles/2024/4/mdcg-issues-guidance-on-investigator-s-brochure-fo Regulatory Focus en 2024-04-22 MDCG issues guidance on Investigators Brochure for medical device studies https://www.raps.org/news-and-articles/news-articles/2024/4/study-many-non-oncologic-surrogate-markers-lack-me Regulatory Focus en 2024-04-22 Study: Many non-oncologic surrogate markers lack meta-analyses linking them to outcomes https://www.raps.org/news-and-articles/news-articles/2024/4/recon-bms-inks-$380m-car-t-manufacturing-deal-with Regulatory Focus en 2024-04-22 Recon: BMS inks 380M CAR-T manufacturing deal with Cellares Supreme Court tosses out Vandas sleep disorder drug patent case https://www.raps.org/news-and-articles/news-articles/2024/4/asia-pacific-roundup-tga-seeks-feedback-on-flexibl Regulatory Focus en 2024-04-22 Asia-Pacific Roundup: TGA seeks feedback on flexible formats for medical device instructions for use https://www.raps.org/news-and-articles/news-articles/2023/4/this-week-at-fda-califf-faces-appropriations-grill Regulatory Focus en 2024-04-19 This Week at FDA: Califf faces appropriations grilling, Woodcocks next steps, warning letters, and more https://www.raps.org/news-and-articles/news-articles/2024/4/fda-official-biowaiver-framework-needed-for-modifi Regulatory Focus en 2024-04-19 FDA official: Biowaiver framework needed for modified release generics https://www.raps.org/news-and-articles/news-articles/2024/4/berlin-tips-euro-convergence-regulatory Regulatory Focus en 2024-04-19 What to do in Berlin while youre visiting for RAPS Euro Convergence 2024 https://www.raps.org/news-and-articles/news-articles/2024/4/who-issues-guidance-on-nitrosamine-controls-in-dru Regulatory Focus en 2024-04-19 WHO issues guidance on nitrosamine controls in drug manufacturing https://www.raps.org/news-and-articles/news-articles/2024/4/regulators-explain-process-for-requesting-real-wor Regulatory Focus en 2024-04-18 Regulators explain process for requesting real-world evidence studies by EMA https://www.raps.org/news-and-articles/news-articles/2024/4/shuren-cdrh-reimagining-medtech-premarket-review-p Regulatory Focus en 2024-04-18 Shuren: CDRH reimagining medtech premarket review process https://www.raps.org/news-and-articles/news-articles/2024/4/recon-lilly-s-zepound-reduces-obstructive-sleep-ap Regulatory Focus en 2024-04-18 Recon: Lillys Zepbound reduces obstructive sleep apnea in phase 3 trials Sage abandons Parkinsons candidate after mid-stage study flop https://www.raps.org/news-and-articles/news-articles/2024/4/euro-roundup-ema-seeks-feedback-on-quality,-therap Regulatory Focus en 2024-04-18 Euro Roundup: EMA seeks feedback on quality, therapeutic equivalence of inhaled drugs https://www.raps.org/news-and-articles/news-articles/2024/4/ich-m13a-be-testing-guideline-expected-to-be-adopt Regulatory Focus en 2024-04-17 ICH M13A BE testing guideline expected to be adopted this summer https://www.raps.org/news-and-articles/news-articles/2024/4/fda-publishes-new-dataset-to-aid-medical-device-bi Regulatory Focus en 2024-04-17 FDA publishes new dataset to aid medical device biocompatibility testing https://www.raps.org/news-and-articles/news-articles/2024/4/fda-officials-say-fy-2025-budget-increase-needed-t Regulatory Focus en 2024-04-16 FDA officials say FY 2025 budget increase needed to offset inflationary pay increases https://www.raps.org/news-and-articles/news-articles/2024/4/fda-officials-offer-advice-on-smooth-be-studies,-c Regulatory Focus en 2024-04-16 FDA officials offer advice on smooth BE studies, comparative analyses for combo products https://www.raps.org/news-and-articles/news-articles/2024/4/latin-america-roundup-brazil-to-recognize-other-ag Regulatory Focus en 2024-04-16 Latin America Roundup: Brazil to recognize other agencies decisions on devices https://www.raps.org/news-and-articles/news-articles/2024/4/recon-j-j-device-sales-fall-short-in-q1;-boehringe Regulatory Focus en 2024-04-16 Recon: JJ device sales fall short in Q1 Boehringer Ingelheim plans to launch 25 products by 2030 https://www.raps.org/news-and-articles/news-articles/2024/4/pharmaceutical-stability-testing-an-overview-of-st Regulatory Focus en 2024-04-16 Pharmaceutical stability testing: An overview of stability https://www.raps.org/news-and-articles/news-articles/2024/4/fda-launches-new-clinical-trial-center-to-improve Regulatory Focus en 2024-04-15 FDA launches new clinical trial center to improve innovation, communication https://www.raps.org/news-and-articles/news-articles/2024/4/fda-aims-for-greater-use-of-remote-assessments-for Regulatory Focus en 2024-04-15 FDA aims for greater use of remote assessments for low-risk facilities https://www.raps.org/news-and-articles/news-articles/2024/4/asia-pacific-roundup-japan’s-pmda-revises-position Regulatory Focus en 2024-04-15 Asia-Pacific Roundup: Japans PMDA revises position on electronic study data for new drug applications https://www.raps.org/news-and-articles/news-articles/2024/4/recon-fda-places-clinical-hold-on-neumora’s-schizo Regulatory Focus en 2024-04-15 Recon: FDA places clinical hold on Neumoras schizophrenia drug trial WHO issues warning after falsified cough syrup ingredients seized in Pakistan https://www.raps.org/news-and-articles/news-articles/2024/4/this-week-at-fda-califf-faces-house-oversight-comm Regulatory Focus en 2024-04-12 This Week at FDA: Califf faces House Oversight committee, diversity plans on the horizon, and more https://www.raps.org/news-and-articles/news-articles/2024/4/fda-officials-discuss-strategies-for-answer-ready Regulatory Focus en 2024-04-12 FDA officials discuss strategies for answer-ready controlled correspondence https://www.raps.org/news-and-articles/news-articles/2024/4/eu-parliament’s-plan-to-link-market-exclusivity-to Regulatory Focus en 2024-04-12 EU Parliaments plan to link market exclusivity to unmet need ethically difficult https://www.raps.org/news-and-articles/news-articles/2023/10/cybersecurity-regulatory-affairs-medical-devices Regulatory Focus en 2024-04-12 Regulatory professionals really cant ignore cybersecurity anymore https://www.raps.org/news-and-articles/news-articles/2024/4/european-parliament-adopts-pharmaceutical-reform-p Regulatory Focus en 2024-04-11 European Parliament adopts pharmaceutical reform package https://www.raps.org/news-and-articles/news-articles/2024/4/court-orders-philips-to-stop-cpap,-bipap,-ventilat Regulatory Focus en 2024-04-11 Court orders Philips to stop CPAP, BiPAP, ventilator production https://www.raps.org/news-and-articles/news-articles/2024/4/fda-officials-offer-advice-for-successful-suitabil Regulatory Focus en 2024-04-11 FDA officials offer advice for successful suitability petitions https://www.raps.org/news-and-articles/news-articles/2024/4/recon-drug-shortages-climbed-to-record-high-in-q4; Regulatory Focus en 2024-04-11 Recon: Drug shortages climbed to record high in Q4 Vertex to acquire Alpine Immune for nearly 5 billion https://www.raps.org/news-and-articles/news-articles/2024/4/euro-roundup-edqm-adopts-positions-on-phage-therap Regulatory Focus en 2024-04-11 Euro Roundup: EDQM adopts positions on phage therapies, CEP application content https://www.raps.org/news-and-articles/news-articles/2024/4/health-equity-as-a-strategic-priority-fda-and-heal Regulatory Focus en 2024-04-11 Health equity as a strategic priority: FDA and Health Canada initiatives https://www.raps.org/news-and-articles/news-articles/2022/11/chinas-digital-health-regulatory-framework-for-sam Regulatory Focus en 2024-04-11 Chinas digital health regulatory framework for SaMD https://www.raps.org/news-and-articles/news-articles/2024/4/nordic-regulatory-networking-group-raps Regulatory Focus en 2024-04-10 Introducing the RAPS Nordic Local Networking Group https://www.raps.org/news-and-articles/news-articles/2024/4/drug-shortages-study-examines-pandemic-supply-chai Regulatory Focus en 2024-04-09 Drug shortages: Study examines pandemic supply chain, HHS proposes resilience incentive https://www.raps.org/news-and-articles/news-articles/2024/4/fda-statistician-offers-tips-for-evaluating-wearab Regulatory Focus en 2024-04-09 FDA statistician offers tips for evaluating wearables for clinical trials https://www.raps.org/news-and-articles/news-articles/2024/4/recon-pfizer-posts-positive-phase-3-data-for-rsv-v Regulatory Focus en 2024-04-09 Recon: Pfizer posts positive Phase 3 data for RSV vaccine in adults 18 and older Novartis to cut 680 product development jobs https://www.raps.org/news-and-articles/news-articles/2024/4/stakeholders-respond-to-senate-ldt-reform-inquiry Regulatory Focus en 2024-04-08 Stakeholders respond to Senate LDT reform inquiry https://www.raps.org/news-and-articles/news-articles/2024/4/study-accelerated-approvals-leave-lingering-uncert Regulatory Focus en 2024-04-08 Study: Accelerated approvals leave lingering uncertainty about cancer drugs benefits https://www.raps.org/news-and-articles/news-articles/2024/4/asia-pacific-roundup-tga-officers-execute-search-w Regulatory Focus en 2024-04-08 Asia-Pacific Roundup: TGA officers execute search warrant in compounded semaglutide investigation https://www.raps.org/news-and-articles/news-articles/2024/4/recon-fda-approves-j-j’s,-legend’s-carvykti-for-tr Regulatory Focus en 2024-04-08 Recon: FDA approves JJs, Legends Carvykti for treating second-line multiple myeloma FDA rejects Supernus Parkinsons disease combo yet again https://www.raps.org/news-and-articles/news-articles/2024/4/this-week-at-fda-hhs-supply-chain-white-paper,-upc Regulatory Focus en 2024-04-05 This Week at FDA: HHS supply chain white paper, upcoming FDA meetings, and more https://www.raps.org/news-and-articles/news-articles/2024/4/fda-criticized-for-approval-of-genetic-test-for-op Regulatory Focus en 2024-04-05 FDA criticized for approval of genetic test for opioid addiction risk https://www.raps.org/news-and-articles/news-articles/2024/4/ema-says-it-will-consider-conditional-approval-for Regulatory Focus en 2024-04-05 EMA says it will consider conditional approval for NASH drugs using intermediate endpoints https://www.raps.org/news-and-articles/news-articles/2024/4/fda-biostatistician-recommends-transparency,-early Regulatory Focus en 2024-04-04 FDA biostatistician recommends transparency, early conversation with reviewers https://www.raps.org/news-and-articles/news-articles/2024/4/euro-roundup-efpia-warns-hta-changes-could-hamper Regulatory Focus en 2024-04-04 Euro Roundup: EFPIA warns HTA changes could hamper drug access https://www.raps.org/news-and-articles/news-articles/2024/4/recon-amylyx-withdraws-als-drug-from-us-and-canada Regulatory Focus en 2024-04-04 Recon: Amylyx withdraws ALS drug from US and Canada Sanofi to settle 4,000 US Zantac cancer lawsuits https://www.raps.org/news-and-articles/news-articles/2024/4/study-few-fda-approved-targeted-cancer-drugs-meet Regulatory Focus en 2024-04-04 Study: Few FDA-approved targeted cancer drugs meet ESMO benefit benchmarks https://www.raps.org/news-and-articles/news-articles/2024/4/fda-reprimands-test-makers-over-improper-severity Regulatory Focus en 2024-04-03 FDA reprimands test makers over improper severity ratings, marketing unauthorized diagnostic https://www.raps.org/news-and-articles/news-articles/2024/4/belgium-regulatory-affairs-networking-group Regulatory Focus en 2024-04-03 Introducing the RAPS Belgium Local Networking Group https://www.raps.org/news-and-articles/news-articles/2024/4/fda-turns-attention-to-data-integrity-lapses-at-te Regulatory Focus en 2024-04-02 FDA turns attention to data integrity lapses at testing sites in new guidance https://www.raps.org/news-and-articles/news-articles/2024/4/latin-america-roundup-mexico,-el-salvador-seek-to Regulatory Focus en 2024-04-02 Latin America Roundup: Mexico, El Salvador join IMDRF as affiliates https://www.raps.org/news-and-articles/news-articles/2024/4/recon-fda-approves-abbott’s-triclip-heart-valve-re Regulatory Focus en 2024-04-02 Recon: FDA approves Abbotts TriClip heart valve repair device Teva, Viatris revive patent challenge against JJ schizophrenia drug https://www.raps.org/news-and-articles/news-articles/2024/4/regulatory-affairs-leadership Regulatory Focus en 2024-04-02 What makes a regulatory leader 7 leadership and business lessons for regulatory professionals https://www.raps.org/news-and-articles/news-articles/2024/4/regulatory-affairs-conference-europe-convergence Regulatory Focus en 2024-04-02 RAPS Euro Convergence 2024: your guide to the most comprehensive regulatory affairs conference in Europe https://www.raps.org/news-and-articles/news-articles/2024/4/fda-finalizes-guidance-on-electronic-submission-of Regulatory Focus en 2024-04-01 FDA finalizes guidance on electronic submission of BABE adverse event reports to FAERS https://www.raps.org/news-and-articles/news-articles/2024/4/industry-wants-to-avoid-surprises-in-remote-regula Regulatory Focus en 2024-04-01 Industry wants to avoid surprises in remote regulatory assessments https://www.raps.org/news-and-articles/news-articles/2024/4/recon-astrazeneca’s-voydeya-for-rare-blood-disorde Regulatory Focus en 2024-04-01 Recon: AstraZenecas Voydeya for rare blood disorder wins FDA approval FDA delays review of Biogens and Eisais injectable Leqembi https://www.raps.org/news-and-articles/news-articles/2024/4/asia-pacific-roundup-japans-pmda-translates-updat Regulatory Focus en 2024-04-01 Asia-Pacific Roundup: Japans PMDA translates updated biosimilars guideline https://www.raps.org/news-and-articles/news-articles/2024/3/fda-shifts-ind-safety-reporting-over-to-faers-in-f Regulatory Focus en 2024-03-29 FDA shifts IND safety reporting over to FAERS in finalized guidance https://www.raps.org/news-and-articles/news-articles/2024/3/this-week-at-fda-cms-inflation-rebates,-ftc-steps Regulatory Focus en 2024-03-29 This Week at FDA: CMS inflation rebates, FTC steps into Amneal patent dispute, and a new GAO report https://www.raps.org/news-and-articles/news-articles/2024/3/fda-proposes-animal-study-requirements-for-dental Regulatory Focus en 2024-03-29 FDA proposes animal study requirements for dental bone grafts https://www.raps.org/news-and-articles/news-articles/2024/3/pharma-groups-call-for-changes-to-fda’s-potency-as Regulatory Focus en 2024-03-28 Pharma groups call for changes to FDAs potency assurance guidance https://www.raps.org/news-and-articles/news-articles/2024/3/fda-launches-new-quantitative-medicine-center-of-e Regulatory Focus en 2024-03-28 FDA launches new Quantitative Medicine Center of Excellence https://www.raps.org/news-and-articles/news-articles/2024/3/device-makers-ask-fda-for-clarification,-exception Regulatory Focus en 2024-03-28 Device makers ask FDA for clarification, exceptions to metallic coating guidance https://www.raps.org/news-and-articles/news-articles/2024/3/recon-fda-approves-akebia’s-anemia-drug-vafseo;-us Regulatory Focus en 2024-03-28 Recon: FDA approves Akebias anemia drug Vafseo US senators told WuXi AppTec shared companies IP with Chinese government https://www.raps.org/news-and-articles/news-articles/2024/3/euro-roundup-ema-urges-sponsors-to-start-ctis-swit Regulatory Focus en 2024-03-28 Euro Roundup: EMA urges sponsors to start CTIS switch soon https://www.raps.org/news-and-articles/news-articles/2024/3/gao-report-recommends-fda-evaluate-how-it-recruits Regulatory Focus en 2024-03-27 GAO report recommends FDA evaluate how it recruits, retains BIMO investigators https://www.raps.org/news-and-articles/news-articles/2024/3/fda-specifies-number-of-samples-to-retain-for-ba-b Regulatory Focus en 2024-03-26 FDA reduces number of samples to retain for BABE testing https://www.raps.org/news-and-articles/news-articles/2024/3/european-commission-proposes-updates-to-medical-de Regulatory Focus en 2024-03-26 European Commission proposes updates to medical device phthalates guidelines https://www.raps.org/news-and-articles/news-articles/2024/3/stakeholders-seek-to-reshape-fda’s-guidance-for-ma Regulatory Focus en 2024-03-26 Stakeholders seek to reshape FDAs guidance for master protocols https://www.raps.org/news-and-articles/news-articles/2024/3/recon-supreme-court-seems-skeptical-of-mifepriston Regulatory Focus en 2024-03-26 Recon: Supreme Court seems skeptical of mifepristone challenge Lawmakers query FDA on Neuralink inspection https://www.raps.org/news-and-articles/news-articles/2024/3/fda-tries-again-to-ban-electroshock-devices Regulatory Focus en 2024-03-25 FDA tries again to ban electrical stimulation devices https://www.raps.org/news-and-articles/news-articles/2024/3/asia-pacific-roundup-new-zealand-updates-pharmacov Regulatory Focus en 2024-03-25 Asia-Pacific Roundup: New Zealand updates pharmacovigilance guideline https://www.raps.org/news-and-articles/news-articles/2024/3/ema-revises-draft-guideline-on-data-to-support-cli Regulatory Focus en 2024-03-25 EMA revises draft guideline on data to support clinical trials for ATMPs https://www.raps.org/news-and-articles/news-articles/2024/3/recon-supreme-court-to-hear-arguments-in-mifeprist Regulatory Focus en 2024-03-25 Recon: Supreme Court to hear arguments in mifepristone case on Tuesday Novo Nordisk to buy Cardior Pharmaceuticals in 11B https://www.raps.org/news-and-articles/news-articles/2024/3/this-week-at-fda-lawmakers-spar-over-ldt-rule,-new Regulatory Focus en 2024-03-22 This Week at FDA: Lawmakers spar over LDT rule, new guidances, and more https://www.raps.org/news-and-articles/news-articles/2024/3/regulators-cite-need-to-involve-diverse-patient-gr Regulatory Focus en 2024-03-22 Regulators cite need to involve diverse patient groups in decision making https://www.raps.org/news-and-articles/news-articles/2024/3/expert-recent-ecj-ruling-could-lead-to-standards-d Regulatory Focus en 2024-03-22 Expert: Recent ECJ ruling could lead to standards development tumult https://www.raps.org/news-and-articles/news-articles/2024/3/ctis,-eudract,-and-other-supporting-platforms-for Regulatory Focus en 2024-03-22 CTIS, EudraCT, and other supporting platforms for the EU CTR https://www.raps.org/news-and-articles/news-articles/2024/3/eu-official-regulatory-requirements-for-conditiona Regulatory Focus en 2024-03-21 EU official: Regulatory requirements for conditional marketing authorization evolving https://www.raps.org/news-and-articles/news-articles/2024/3/fda-offers-guidance-on-observational-studies-as-rw Regulatory Focus en 2024-03-21 FDA offers guidance on observational studies as RWE https://www.raps.org/news-and-articles/news-articles/2024/3/industry-clamors-for-clarity-on-fda’s-advanced-man Regulatory Focus en 2024-03-21 Industry clamors for clarity on FDAs advanced manufacturing designation program https://www.raps.org/news-and-articles/news-articles/2024/3/recon-merck’s-combination-therapy-for-lung-cancer Regulatory Focus en 2024-03-21 Recon: Mercks combination therapy for lung cancer falters in phase 3 trial Medicare to cover Wegovy for heart disease https://www.raps.org/news-and-articles/news-articles/2024/3/euro-roundup-european-commission-proposes-streamli Regulatory Focus en 2024-03-21 Euro Roundup: European Commission proposes streamlining regulations to boost biomanufacturing https://www.raps.org/news-and-articles/news-articles/2024/3/quality-sumatha-kondabolu-interview Regulatory Focus en 2024-03-20 How Sumatha Kondabolu learned quality assurance and how RAPS membership helps her https://www.raps.org/news-and-articles/news-articles/2024/3/fda-proposes-rule-for-difficult-to-compound-drugs, Regulatory Focus en 2024-03-20 FDA proposes rule for difficult-to-compound drugs, drug categories https://www.raps.org/news-and-articles/news-articles/2024/3/interview-ema’s-peter-arlett-provides-update-on-da Regulatory Focus en 2024-03-19 Interview: EMAs Peter Arlett provides update on DARWIN EU https://www.raps.org/news-and-articles/news-articles/2024/3/fda-warns-consumers-against-using-plastic-syringes Regulatory Focus en 2024-03-19 FDA warns consumers against using plastic syringes made in China https://www.raps.org/news-and-articles/news-articles/2024/3/latin-america-roundup-brazil-and-colombia-advance Regulatory Focus en 2024-03-19 Latin America Roundup: Brazil and Colombia advance public drug-making initiatives https://www.raps.org/news-and-articles/news-articles/2024/3/european-parliament-committee-adopts-proposals-to Regulatory Focus en 2024-03-19 European Parliament committee adopts proposals to revamp pharma legislation https://www.raps.org/news-and-articles/news-articles/2024/3/recon-astrazeneca-to-buy-fusion-in-targeted-radiat Regulatory Focus en 2024-03-19 Recon: AstraZeneca to buy Fusion in targeted radiation deal valued at 2B Seelos ALS treatment fails in mid-stage trial https://www.raps.org/news-and-articles/news-articles/2024/3/eu-patient-groups-say-proposed-definition-of-‘unme Regulatory Focus en 2024-03-18 EU patient groups say proposed definition of unmet medical need is too restrictive https://www.raps.org/news-and-articles/news-articles/2024/3/fda-wants-sponsors-to-test-devices-that-may-cause Regulatory Focus en 2024-03-18 FDA wants sponsors to test devices that may cause tissue temperature changes https://www.raps.org/news-and-articles/news-articles/2024/3/recon-fda-approves-orchard’s-gene-therapy-lenmeldy Regulatory Focus en 2024-03-18 Recon: FDA approves Orchards gene therapy Lenmeldy Pfizer sells partial stake in Haleon https://www.raps.org/news-and-articles/news-articles/2024/3/asia-pacific-roundup-australia’s-tga-consults-on-u Regulatory Focus en 2024-03-18 Asia-Pacific Roundup: Australias TGA consults on updated draft companion diagnostics guidance https://www.raps.org/news-and-articles/news-articles/2024/3/this-week-at-fda-final-eto-rule,-imdrf-meeting,-an Regulatory Focus en 2024-03-15 This Week at FDA: Final EtO rule, IMDRF meeting, and more https://www.raps.org/news-and-articles/news-articles/2024/3/european-parliament-committee-proposes-changes-to Regulatory Focus en 2024-03-15 European Parliament committee proposes changes to pharma legislation https://www.raps.org/news-and-articles/news-articles/2024/3/epa-finalizes-rule-to-reduce-eto-emissions-from-st Regulatory Focus en 2024-03-14 EPA finalizes rule to reduce EtO emissions from sterilization facilities https://www.raps.org/news-and-articles/news-articles/2024/3/experts-discuss-regulatory-approaches-for-ai-and-c Regulatory Focus en 2024-03-14 Experts discuss regulatory approaches for AI and current industry practices https://www.raps.org/news-and-articles/news-articles/2024/3/fda-offers-guidance-on-minor-label-changes-for-otc Regulatory Focus en 2024-03-14 FDA offers guidance on minor label changes for OTC drugs https://www.raps.org/news-and-articles/news-articles/2024/3/euro-roundup-kyriakides-defends-ehds-but-warns-€1b Regulatory Focus en 2024-03-14 Euro Roundup: Kyriakides defends EHDS but warns 1B budget cut will force difficult decisions https://www.raps.org/news-and-articles/news-articles/2024/3/recon-astrazeneca-to-buy-amolyt-for-$1-05b;-bio-cu Regulatory Focus en 2024-03-14 Recon: AstraZeneca to buy Amolyt for 105B BIO cuts ties with WuXi to quell US security concerns https://www.raps.org/news-and-articles/news-articles/2024/3/raps-fellows-info-applications Regulatory Focus en 2024-03-14 Being recognized as a RAPS Fellow: How to maximize the application process https://www.raps.org/news-and-articles/news-articles/2024/3/bumpus-discusses-adcomms,-animal-testing,-and-ai Regulatory Focus en 2024-03-13 Bumpus discusses adcomms, animal testing, and AI https://www.raps.org/news-and-articles/news-articles/2024/3/eu-regulators-and-industry-clash-on-pharmaceutical Regulatory Focus en 2024-03-13 EU regulators and industry clash on pharmaceutical reform package https://www.raps.org/news-and-articles/news-articles/2024/3/fda-proposes-updates-to-device-cybersecurity-guida Regulatory Focus en 2024-03-13 FDA proposes updates to device cybersecurity guidance https://www.raps.org/news-and-articles/news-articles/2024/3/european-commission-finalizes-plan-to-streamline-v Regulatory Focus en 2024-03-13 European Commission finalizes plan to streamline variation process https://www.raps.org/news-and-articles/news-articles/2024/3/regulators-imdrf-members-offer-updates-on-new-work Regulatory Focus en 2024-03-12 IMDRF: Regulators offer updates on new working group documents https://www.raps.org/news-and-articles/news-articles/2024/3/uk-seeks-to-curb-bias-in-medical-devices Regulatory Focus en 2024-03-12 UK seeks to curb bias in medical devices https://www.raps.org/news-and-articles/news-articles/2024/3/fda-wants-$7-2b-for-product-safety,-public-health Regulatory Focus en 2024-03-12 FDA wants 72B for product safety, public health in Bidens FY 2025 budget https://www.raps.org/news-and-articles/news-articles/2024/3/recon-pfizer’s-adcetris-shows-promise-in-phase-3-b Regulatory Focus en 2024-03-12 Recon: Pfizers Adcetris shows promise in phase 3 blood cancer study FDA reviewers raise concerns about Gerons blood disorder drug https://www.raps.org/news-and-articles/news-articles/2024/3/stakeholders-discuss-potential-imdrf-reliance-play Regulatory Focus en 2024-03-11 Stakeholders discuss potential IMDRF reliance playbook, guidance https://www.raps.org/news-and-articles/news-articles/2024/3/fda-updates-early-alzheimer’s-drug-development-gui Regulatory Focus en 2024-03-11 FDA updates early Alzheimers drug development guidance to add support for biomarkers, surrogate endpoints https://www.raps.org/news-and-articles/news-articles/2024/3/asia-pacific-roundup-tga-tightens-rules-on-medical Regulatory Focus en 2024-03-11 Asia-Pacific Roundup: TGA tightens rules on medical aesthetic ads after rise in marketing https://www.raps.org/news-and-articles/news-articles/2024/3/recon-fda-approves-novo’s-wegovy-to-lower-cardiova Regulatory Focus en 2024-03-11 Recon: FDA approves Novos Wegovy to lower cardiovascular risks Acadias schizophrenia drug misses primary goal in Phase 3 trial https://www.raps.org/news-and-articles/news-articles/2024/3/the-impact-of-the-eu-ivdr-on-clinical-trials Regulatory Focus en 2024-03-08 The impact of the EU IVDR on clinical trials https://www.raps.org/news-and-articles/news-articles/2024/1/medical-promotional-review-current-trends,-challen Regulatory Focus en 2024-03-08 Medical promotional review: Current trends, challenges, and strategies for success https://www.raps.org/news-and-articles/news-articles/2024/1/will-x-mark-the-spot-for-pharmaceutical-advertisin Regulatory Focus en 2024-03-08 Will X mark the spot for pharmaceutical advertising https://www.raps.org/news-and-articles/news-articles/2023/12/impurities-in-drug-substances-and-drug-product-(1) Regulatory Focus en 2024-03-08 Impurities in drug substances and drug products: A risk-based approach https://www.raps.org/news-and-articles/news-articles/2024/3/this-week-at-fda-another-budget-cliffhanger,-new-a Regulatory Focus en 2024-03-08 This Week at FDA: Another budget cliffhanger, new adcomm, and a missed EtO deadline https://www.raps.org/news-and-articles/news-articles/2024/3/target-product-profile-can-shorten-development-tim Regulatory Focus en 2024-03-08 Target product profile can shorten development time and reduce costs, experts say https://www.raps.org/news-and-articles/news-articles/2024/3/rf-quarterly,-march-2024-the-eu-ctr-–-navigating-t Regulatory Focus en 2024-03-08 RF Quarterly, March 2024: The EU CTR Navigating the transition https://www.raps.org/news-and-articles/news-articles/2024/3/the-eu-clinical-trials-regulation-experiences-from Regulatory Focus en 2024-03-08 The EU Clinical Trials Regulation: Experiences from the first 18 months https://www.raps.org/news-and-articles/news-articles/2024/3/the-emerging-transparency-paradigm-for-clinical-tr Regulatory Focus en 2024-03-08 The emerging transparency paradigm for clinical trials in Europe https://www.raps.org/news-and-articles/news-articles/2024/3/the-eu-ctr-opportunities,-challenges,-and-lessons Regulatory Focus en 2024-03-08 The EU CTR: Opportunities, challenges, and lessons learned https://www.raps.org/news-and-articles/news-articles/2024/3/strategic-considerations-and-submission-processes Regulatory Focus en 2024-03-08 Strategic considerations and submission processes under the EU CTR https://www.raps.org/news-and-articles/news-articles/2024/3/global-regulatory-strategy-conference-recap Regulatory Focus en 2024-03-07 Diving deep on global regulatory strategy at the newest RAPS event https://www.raps.org/news-and-articles/news-articles/2024/3/experts-discuss-how-to-avoid-step,-breakthrough-de Regulatory Focus en 2024-03-07 Experts discuss how to avoid STeP, breakthrough device submission missteps https://www.raps.org/news-and-articles/news-articles/2024/3/industry-advises-fda-not-to-issue-more-guidances-w Regulatory Focus en 2024-03-07 Industry advises FDA not to issue more guidances without public comment https://www.raps.org/news-and-articles/news-articles/2024/3/european-commission-proposes-framework-for-joint-c Regulatory Focus en 2024-03-07 European Commission proposes framework for joint clinical assessments https://www.raps.org/news-and-articles/news-articles/2024/3/recon-boehringer-ingelheim-slated-to-cap-asthma-in Regulatory Focus en 2024-03-07 Recon: Boehringer slated to cap asthma inhaler costs at 35 a month Novo surges on early-stage obesity drug data https://www.raps.org/news-and-articles/news-articles/2024/3/euro-roundup-ema-shares-draft-guideline-smaller-si Regulatory Focus en 2024-03-07 Euro Roundup: EMA shares draft guideline on smaller-sized allergy trials https://www.raps.org/news-and-articles/news-articles/2024/3/fda-official-hopes-imdrf-meeting-will-attract-new Regulatory Focus en 2024-03-05 FDA official hopes IMDRF meeting will attract new members https://www.raps.org/news-and-articles/news-articles/2024/3/recon-congress-gives-fda-austere-budget-but-seeks Regulatory Focus en 2024-03-05 Recon: Congress gives FDA tight budget but seeks to boost inspections Perrigos OTC birth control drug Opill begins shipping in US https://www.raps.org/news-and-articles/news-articles/2024/3/uk’s-mhra-approves-first-drug-under-international Regulatory Focus en 2024-03-05 UKs MHRA approves first drug under international recognition procedure https://www.raps.org/news-and-articles/news-articles/2024/3/latin-america-roundup-colombia-confronts-insulin-s Regulatory Focus en 2024-03-05 Latin America Roundup: Colombia confronts insulin shortage https://www.raps.org/news-and-articles/news-articles/2024/3/fda-issues-more-warning-letters-to-firms-making-co Regulatory Focus en 2024-03-04 FDA issues more warning letters to firms making contaminated eye drops https://www.raps.org/news-and-articles/news-articles/2024/3/fda-recommends-participants-receive-key-trial-info Regulatory Focus en 2024-03-04 FDA recommends participants receive key trial information early, concisely https://www.raps.org/news-and-articles/news-articles/2024/3/asia-pacific-roundup-cdsco-seeks-feedback-on-biolo Regulatory Focus en 2024-03-04 Asia-Pacific Roundup: CDSCO seeks feedback on biological postapproval change guidance https://www.raps.org/news-and-articles/news-articles/2024/3/recon-perrigo-launches-over-the-counter-birth-cont Regulatory Focus en 2024-03-04 Recon: Perrigo launches over-the-counter birth control pill in the US Drugmakers make counteroffers in first round of Medicare price negotiations https://www.raps.org/news-and-articles/news-articles/2024/3/combination-products-summit-dia-raps Regulatory Focus en 2024-03-04 Joint Summit Proposes Pragmatic Solutions for Combination Products in Europe https://www.raps.org/news-and-articles/news-articles/2024/3/this-week-at-fda-government-shutdown-averted,-fda Regulatory Focus en 2024-03-01 This Week at FDA: Government shutdown averted, FDA updates device standards, and more https://www.raps.org/news-and-articles/news-articles/2024/3/generic-group-says-fda’s-ophthalmic-guideline-shou Regulatory Focus en 2024-03-01 Generic group says FDAs ophthalmic guideline should align with ICH Q3BR2 https://www.raps.org/news-and-articles/news-articles/2024/2/fda-finalizes-guidance-on-designing-pharmacology-s Regulatory Focus en 2024-02-29 FDA finalizes guidance on designing pharmacology studies for antibody-drug conjugates https://www.raps.org/news-and-articles/news-articles/2024/2/recon-fda-inspectors-cited-neuralink-for-animal-te Regulatory Focus en 2024-02-29 Recon: FDA inspectors cited Neuralink for animal testing issues Fake weight loss drugs worry FDA chief https://www.raps.org/news-and-articles/news-articles/2024/2/euro-roundup-ema-seeks-feedback-on-planned-covid-a Regulatory Focus en 2024-02-29 Euro Roundup: EMA seeks feedback on planned COVID antiviral, antibody guidance https://www.raps.org/news-and-articles/news-articles/2024/2/raine-to-step-down-after-leading-mhra-through-brex Regulatory Focus en 2024-02-28 Raine to step down after leading MHRA through Brexit, COVID-19 https://www.raps.org/news-and-articles/news-articles/2024/2/marks-talks-otp-staffing,-gene-therapies,-and-more Regulatory Focus en 2024-02-27 Marks talks OTP staffing, gene therapies, and more https://www.raps.org/news-and-articles/news-articles/2024/2/fda-proposes-waiving-device-registration-fees-for Regulatory Focus en 2024-02-27 FDA proposes waiving device registration fees for firms making less than 1M, in bankruptcy https://www.raps.org/news-and-articles/news-articles/2024/2/fda-officials-argue-for-retaining-advisory-committ Regulatory Focus en 2024-02-27 FDA officials argue for retaining advisory committee votes, welcome return to face-to-face meetings https://www.raps.org/news-and-articles/news-articles/2024/2/cell-therapy-equipment-regulatory-guidelines-and-f Regulatory Focus en 2024-02-27 Cell therapy equipment: regulatory guidelines and feedback opportunities https://www.raps.org/news-and-articles/news-articles/2024/2/recon-fda-to-increase-inspections-of-indian-drugma Regulatory Focus en 2024-02-27 Recon: FDA to increase inspections of Indian drugmakers FDA rejects Minervas schizophrenia drug https://www.raps.org/news-and-articles/news-articles/2024/2/healthcare-labeling-regulatory-affairs Regulatory Focus en 2024-02-27 She says labeling is where all the action is Let her explain https://www.raps.org/news-and-articles/news-articles/2024/2/fda-official-discusses-use-cases,-limits-for-devic Regulatory Focus en 2024-02-26 FDA official discusses use cases, limits for device PCCPs https://www.raps.org/news-and-articles/news-articles/2024/2/industry-calls-for-changes-in-fda’s-rwe-guidance-f Regulatory Focus en 2024-02-26 Industry calls for changes in FDAs RWE guidance for devices https://www.raps.org/news-and-articles/news-articles/2024/2/recon-doj-subpoenas-biomarin-over-sponsored-testin Regulatory Focus en 2024-02-26 Recon: DoJ subpoenas BioMarin over sponsored testing programs Boehringer, Zealands weight loss drug shows promise in mid-stage MASH study https://www.raps.org/news-and-articles/news-articles/2024/2/asia-pacific-roundup-pakistan-floats-guideline-cha Regulatory Focus en 2024-02-26 Asia-Pacific Roundup: Pakistan floats guideline changes on GCP inspections and more https://www.raps.org/news-and-articles/news-articles/2024/2/biologics-cmc-regulatory-technical-advice Regulatory Focus en 2024-02-26 How to learn about biologics CMC: advice on technical issues, regulatory strategy, and more https://www.raps.org/news-and-articles/news-articles/2024/2/this-week-at-fda-countdown-to-government-shutdown, Regulatory Focus en 2024-02-23 This Week at FDA: Countdown to government shutdown, FDA warns about data integrity and wearables https://www.raps.org/news-and-articles/news-articles/2024/2/ich-targets-cell-and-gene-therapies,-real-world-da Regulatory Focus en 2024-02-23 ICH targets cell and gene therapies, real-world data as topics ripe for harmonization https://www.raps.org/news-and-articles/news-articles/2024/2/learning-regulatory-affairs-interview Regulatory Focus en 2024-02-23 The power of being a life-long philomath, with Atim Enyenihi https://www.raps.org/news-and-articles/news-articles/2024/2/fda-official-warns-device-makers-over-supply-chain Regulatory Focus en 2024-02-22 FDA official warns device makers over supply chain risks https://www.raps.org/news-and-articles/news-articles/2024/2/euro-roundup-industry-calls-for-uk-government-fund Regulatory Focus en 2024-02-22 Euro Roundup: Industry calls for UK government funding to fix significant capacity issue at MHRA https://www.raps.org/news-and-articles/news-articles/2024/2/industry-urges-fda-to-do-more-to-help-companies-pr Regulatory Focus en 2024-02-22 Industry urges FDA to do more to help companies prepare for DSCSA https://www.raps.org/news-and-articles/news-articles/2024/2/recon-moderna-posts-profits,-sets-sights-on-rsv-ja Regulatory Focus en 2024-02-22 Recon: Moderna posts profits, sets sights on RSV jab United sues FDA over rival Liquidias NDA https://www.raps.org/news-and-articles/news-articles/2024/2/mark-mcclellan-more-alignment-needed-on-rwd-termin Regulatory Focus en 2024-02-21 Mark McClellan: More alignment needed on RWD terminology https://www.raps.org/news-and-articles/news-articles/2024/2/fda-warns-industry-about-potential-data-integrity Regulatory Focus en 2024-02-20 FDA warns industry about potential data integrity issues with third-party labs https://www.raps.org/news-and-articles/news-articles/2024/2/latin-america-roundup-mexico-unveils-ambitious-bio Regulatory Focus en 2024-02-20 Latin America Roundup: Mexico unveils ambitious biosimilar strategy https://www.raps.org/news-and-articles/news-articles/2024/2/recon-abbvie’s-ceo-gonzalez-to-depart-company-afte Regulatory Focus en 2024-02-20 Recon: AbbVies CEO Gonzalez to depart company after 11 years FDA halts two of Rapts mid-stage immunology trials https://www.raps.org/news-and-articles/news-articles/2024/2/the-eu-ctr-opportunities,-challenges,-and-lessons Regulatory Focus en 2024-02-20 The EU CTR: Opportunities, challenges, and lessons learned https://www.raps.org/news-and-articles/news-articles/2024/2/uk-approved-bodies-launch-team-ab-as-mhra-gears-up Regulatory Focus en 2024-02-19 UK approved bodies launch Team-AB as MHRA gears up for new medtech legislation https://www.raps.org/news-and-articles/news-articles/2024/2/ema-proposes-new-guideline-on-non-inferiority-tria Regulatory Focus en 2024-02-19 EMA proposes new guideline on non-inferiority trials https://www.raps.org/news-and-articles/news-articles/2024/1/recon-fda-approves-iovance’s-cell-therapy-amtagvi Regulatory Focus en 2024-02-19 Recon: FDA approves Iovances cell therapy Amtagvi for solid tumors Pfizers inflammatory bowel disease drug authorized in EU https://www.raps.org/news-and-articles/news-articles/2024/2/asia-pacific-roundup-tga-queries-on-managing-medic Regulatory Focus en 2024-02-19 Asia-Pacific Roundup: TGA queries on managing medicine shortages, discontinuations https://www.raps.org/news-and-articles/news-articles/2024/2/this-week-at-fda-marks-testifies-on-vaccine-safety Regulatory Focus en 2024-02-16 This Week at FDA: Marks testifies on vaccine safety, FDA approves new drugs for frostbite, allergic reactions, and more https://www.raps.org/news-and-articles/news-articles/2024/2/ich-consults-on-revised-post-approval-safety-guide Regulatory Focus en 2024-02-16 ICH consults on revised post-approval safety guideline that accounts for digital platforms https://www.raps.org/news-and-articles/news-articles/2024/2/a-note-from-your-2024-raps-eu-board-chair Regulatory Focus en 2024-02-16 A note from your 2024 RAPS EU Board chair https://www.raps.org/news-and-articles/news-articles/2024/2/califf-new-systems-needed-for-bringing-rare-diseas Regulatory Focus en 2024-02-15 Califf: New systems needed for bringing rare disease treatments, at-home devices to market https://www.raps.org/news-and-articles/news-articles/2024/2/fda-officials-discuss-rems-transparency-efforts Regulatory Focus en 2024-02-15 FDA officials discuss REMS transparency efforts https://www.raps.org/news-and-articles/news-articles/2024/2/fda-misses-congressional-deadline-to-update-clinic Regulatory Focus en 2024-02-15 FDA misses congressional deadline to update clinical trial diversity guidance https://www.raps.org/news-and-articles/news-articles/2024/2/recon-pfizer-to-pay-$93m-to-resolve-lipitor-antiru Regulatory Focus en 2024-02-15 Recon: Pfizer to pay 93M to resolve Lipitor antirust complaint FTC to examine group purchasing organizations https://www.raps.org/news-and-articles/news-articles/2024/2/euro-roundup-edqm-shares-top-10-deficiencies-certi Regulatory Focus en 2024-02-15 Euro Roundup: EDQM shares top 10 deficiencies Certificate of Suitability applications https://www.raps.org/news-and-articles/news-articles/2024/2/rcc-regulatory-compliance-certification-exam Regulatory Focus en 2024-02-15 These are the first 70 professionals to ever earn their RCC credentials https://www.raps.org/news-and-articles/news-articles/2024/2/fda-finalizes-guidance-on-charging-for-investigati Regulatory Focus en 2024-02-14 FDA finalizes guidance on charging for investigational drugs https://www.raps.org/news-and-articles/news-articles/2024/2/fda-warns-firms-for-cgmp-violations,-unauthorized Regulatory Focus en 2024-02-13 FDA warns firms for CGMP violations, unauthorized sales of weight-loss drugs https://www.raps.org/news-and-articles/news-articles/2024/2/fda,-ema-officials-say-diverse-pharmacovigilance-s Regulatory Focus en 2024-02-13 FDA, EMA officials say diverse pharmacovigilance strategies, long-term follow-up needed for ATMPs https://www.raps.org/news-and-articles/news-articles/2024/2/recon-pharma-lawsuit-challenging-medicare-drug-pri Regulatory Focus en 2024-02-13 Recon: Pharma lawsuit challenging Medicare drug price negotiations dismissed BioAge raises 170M for obesity combo https://www.raps.org/news-and-articles/news-articles/2024/2/fda-issues-new-draft-guidance-on-data-monitoring-c Regulatory Focus en 2024-02-12 FDA issues new draft guidance on data monitoring committees https://www.raps.org/news-and-articles/news-articles/2024/2/asia-pacific-roundup-pakistan’s-drap-seeks-feedbac Regulatory Focus en 2024-02-12 Asia-Pacific Roundup: Pakistans DRAP seeks feedback on revised clinical trial guidelines https://www.raps.org/news-and-articles/news-articles/2024/2/becerra-warns-mifepristone-case-could-open-door-to Regulatory Focus en 2024-02-12 Becerra warns mifepristone case could open door to challenges against other approvals https://www.raps.org/news-and-articles/news-articles/2024/2/recon-gilead-to-buy-cymabay-for-$4-3b;-fda-approve Regulatory Focus en 2024-02-12 Recon: Gilead to buy CymaBay for 43B FDA approves Takedas oral eosinophilic esophagitis drug https://www.raps.org/news-and-articles/news-articles/2024/2/this-week-at-fda-top-lawmaker-retiring,-fda-announ Regulatory Focus en 2024-02-09 This Week at FDA: Top lawmaker retiring, FDA announces meetings, mifepristone studies retracted https://www.raps.org/news-and-articles/news-articles/2024/2/experts-expect-qmsr-to-spawn-cottage-industry-of-c Regulatory Focus en 2024-02-08 Experts: Expect QMSR to spawn cottage industry of consultants over next two years https://www.raps.org/news-and-articles/news-articles/2024/2/recon-fda-places-gilead’s-blood-cancer-drug-trials Regulatory Focus en 2024-02-08 Recon: FDA places Gileads blood cancer drug trials on hold FDA found quality control lapses at Catalents Bloomington plant https://www.raps.org/news-and-articles/news-articles/2024/2/euro-roundup-swissmedic-requests-prior-notificatio Regulatory Focus en 2024-02-08 Euro Roundup: Swissmedic requests prior notification of new active substance applications https://www.raps.org/news-and-articles/news-articles/2024/2/regulators,-industry-tout-new-approach-for-benefit Regulatory Focus en 2024-02-07 Regulators, industry tout new approach for benefits-risk assessments https://www.raps.org/news-and-articles/news-articles/2024/2/impurities-management-in-drug-products-a-simulated Regulatory Focus en 2024-02-07 Impurities management in drug products: A simulated case study https://www.raps.org/news-and-articles/news-articles/2024/2/lawmakers-voice-concerns-over-fda’s-foreign-inspec Regulatory Focus en 2024-02-06 Lawmakers voice concerns over FDAs foreign inspection program https://www.raps.org/news-and-articles/news-articles/2024/2/latin-america-roundup-brazil,-mexico-lay-out-regul Regulatory Focus en 2024-02-06 Latin America Roundup: Brazil, Mexico lay out regulatory priorities https://www.raps.org/news-and-articles/news-articles/2024/2/fda-finalizes-best-practices-guide-for-postmarketi Regulatory Focus en 2024-02-06 FDA finalizes best practices guide for postmarketing safety studies https://www.raps.org/news-and-articles/news-articles/2024/2/official-fda-modernizing-pharmacovigilance-oversig Regulatory Focus en 2024-02-06 Official: FDA modernizing pharmacovigilance oversight with AI tools https://www.raps.org/news-and-articles/news-articles/2024/2/recon-j-j-sued-over-employer-liability-for-overpay Regulatory Focus en 2024-02-06 Recon: JJ sued over employer liability for overpaying for drugs Lilly terminates Verzenio Phase 3 trial for prostate cancer https://www.raps.org/news-and-articles/news-articles/2024/2/fda-gives-drugmakers-3-weeks-to-begin-reporting-su Regulatory Focus en 2024-02-05 FDA gives drugmakers 3 weeks to begin reporting supply chain data https://www.raps.org/news-and-articles/news-articles/2024/1/sanctions-on-digital-media-in-the-uk Regulatory Focus en 2024-02-05 Sanctions on digital media communication in the UK https://www.raps.org/news-and-articles/news-articles/2024/2/fda-officials-transforming-evidence-generation-to Regulatory Focus en 2024-02-05 FDA officials: Transforming evidence generation to tackle chronic diseases https://www.raps.org/news-and-articles/news-articles/2024/2/asia-pacific-roundup-pakistan’s-drap-issues-warnin Regulatory Focus en 2024-02-05 Asia-Pacific Roundup: Pakistans DRAP issues warning after manufacturers fail to mitigate glycol impurity risk https://www.raps.org/news-and-articles/news-articles/2024/2/recon-novo-holdings-slated-to-buy-catalent-for-$16 Regulatory Focus en 2024-02-05 Recon: Novo Holdings slated to buy Catalent for 165B Amgen, Regeneron pursuing GLP-1 class obesity drugs https://www.raps.org/news-and-articles/news-articles/2024/1/introducing-the-raps-quebec-local-networking-group Regulatory Focus en 2024-02-05 Introducing the RAPS Quebec Local Networking Group https://www.raps.org/news-and-articles/news-articles/2024/2/this-week-at-fda-qmsr-final-rule,-dems-defend-fda’ Regulatory Focus en 2024-02-02 This Week at FDA: QMSR final rule, Dems defend FDAs mifepristone approval, and more https://www.raps.org/news-and-articles/news-articles/2024/2/fda-officials-say-different-communication-methods Regulatory Focus en 2024-02-02 FDA officials say different communication methods needed to ensure AIML transparency https://www.raps.org/news-and-articles/news-articles/2024/2/ema-proposes-waiving-comparative-efficacy-studies Regulatory Focus en 2024-02-02 EMA proposes waiving comparative efficacy studies for certain biosimilars https://www.raps.org/news-and-articles/news-articles/2024/2/fda-proposes-down-classifying-most-high-risk-ivds Regulatory Focus en 2024-02-01 FDA proposes down-classifying most high-risk IVDs https://www.raps.org/news-and-articles/news-articles/2024/2/califf-says-major-effort-underway-to-reform-adviso Regulatory Focus en 2024-02-01 Califf says major effort underway to reform advisory committee meetings https://www.raps.org/news-and-articles/news-articles/2024/2/euro-roundup-politicians-call-for-urgent-fix-to-pr Regulatory Focus en 2024-02-01 Euro Roundup: Politicians call for urgent fix to property problems that are using up EMA resources https://www.raps.org/news-and-articles/news-articles/2024/2/recon-hikma,-ad-firm-settle-us-opioid-suits-for-$5 Regulatory Focus en 2024-02-01 Recon: Hikma, ad firm settle US opioid suits for 500M Novavax announces new layoffs https://www.raps.org/news-and-articles/news-articles/2023/7/eu-general-pharmaceutical-legislation-holds-promis Regulatory Focus en 2024-01-31 EU general pharmaceutical legislation holds promise for combination products https://www.raps.org/news-and-articles/news-articles/2024/1/fda-issues-qmsr-final-rule-with-2-year-transition Regulatory Focus en 2024-01-31 FDA issues QMSR final rule with 2-year transition period https://www.raps.org/news-and-articles/news-articles/2024/1/combination-products-europe-conference-raps-dia Regulatory Focus en 2024-01-31 130 Global Regulators, Health Authorities, Notified Bodies and Industry Partners Gather in Brussels for 2024 Combination Products in the EU https://www.raps.org/news-and-articles/news-articles/2024/1/fda-genome-editing-therapies-may-use-accelerated-a Regulatory Focus en 2024-01-30 FDA: Genome editing therapies may use accelerated approval pathway https://www.raps.org/news-and-articles/news-articles/2024/1/experts-outline-challenges-of-combination-products Regulatory Focus en 2024-01-30 Experts outline challenges of combination products in Europe https://www.raps.org/news-and-articles/news-articles/2024/1/fda-finalizes-guidance-on-developing,-manufacturin Regulatory Focus en 2024-01-30 FDA finalizes guidance on developing, manufacturing CAR T therapies https://www.raps.org/news-and-articles/news-articles/2024/1/fda-proposes-standards-for-collecting-and-reportin Regulatory Focus en 2024-01-30 Clinical trials: FDA proposes new standards for collecting race, ethnicity data https://www.raps.org/news-and-articles/news-articles/2024/1/recon-vertex-non-opioid-pain-reliever-succeeds-in Regulatory Focus en 2024-01-30 Recon: Vertex non-opioid pain reliever succeeds in late-stage trials Neuralink implants brain chip in first human patient https://www.raps.org/news-and-articles/news-articles/2024/1/asia-pacific-roundup-australia’s-tga-seeks-feedbac Regulatory Focus en 2024-01-29 Asia-Pacific Roundup: Australias TGA seeks feedback on fee increases, warns of need to cut costs https://www.raps.org/news-and-articles/news-articles/2024/1/interview-janet-woodcock’s-lasting-influence-on-fd Regulatory Focus en 2024-01-29 Interview: Janet Woodcocks lasting influence on FDA https://www.raps.org/news-and-articles/news-articles/2024/1/fda-updates-guidance-on-remote-regulatory-assessme Regulatory Focus en 2024-01-29 FDA updates guidance on remote regulatory assessments https://www.raps.org/news-and-articles/news-articles/2024/1/recon-philips-no-longer-selling-sleep-apnea-device Regulatory Focus en 2024-01-29 Recon: Philips no longer selling sleep apnea devices in US after FDA consent decree BMS Opdivo posts disappointing post-kidney cancer trial results https://www.raps.org/news-and-articles/news-articles/2024/1/this-week-at-fda-new-guidance,-a-new-super-office, Regulatory Focus en 2024-01-26 This Week at FDA: New guidance, a new super office, and farewell to Janet Woodcock https://www.raps.org/news-and-articles/news-articles/2024/1/fda-guidance-on-quantitative-information-in-dtc-ad Regulatory Focus en 2024-01-26 FDA guidance on quantitative information in DTC advertising: Implications for social media https://www.raps.org/news-and-articles/news-articles/2024/1/sharing-scientific-information-on-unapproved-uses Regulatory Focus en 2024-01-26 Sharing scientific information on unapproved uses: An FDA guidance update https://www.raps.org/news-and-articles/news-articles/2024/1/impurities-in-drug-substances-and-drug-products-ca Regulatory Focus en 2024-01-26 Impurities management in drug substances: A simulated case study https://www.raps.org/news-and-articles/news-articles/2024/1/medcon-2024-to-convene-april-24-26-in-columbus,-oh Regulatory Focus en 2024-01-26 MedCon 2024 to Convene April 24-26 in Columbus, Ohio https://www.raps.org/news-and-articles/news-articles/2024/1/regulators-tout-icmra-pilots,-adoption-of-ich-guid Regulatory Focus en 2024-01-26 Regulators tout ICMRA pilots, adoption of ICH guidelines as major steps toward convergence https://www.raps.org/news-and-articles/news-articles/2024/1/fda-final-guidances-aim-to-streamline-anda-reviews Regulatory Focus en 2024-01-25 FDA final guidances aim to streamline ANDA reviews https://www.raps.org/news-and-articles/news-articles/2024/1/euro-roundup-ema-answers-iris-questions-as-variati Regulatory Focus en 2024-01-25 Euro Roundup: EMA answers IRIS questions as variation and notification notices move to new portal https://www.raps.org/news-and-articles/news-articles/2024/1/recon-fda-officials-offer-updates-on-car-t-safety Regulatory Focus en 2024-01-25 Recon: FDA officials offer updates on CAR-T safety review Haleon recalls some batches of Robitussin over microbial contamination https://www.raps.org/news-and-articles/news-articles/2024/1/navigating Regulatory Focus en 2024-01-25 Navigating the shift to omnichannel marketing https://www.raps.org/news-and-articles/news-articles/2024/1/ema-updates-sme-guide-to-reflect-clinical-trial-re Regulatory Focus en 2024-01-24 EMA updates SME guide to reflect clinical trial reporting requirements https://www.raps.org/news-and-articles/news-articles/2024/1/commission-proposes-to-extend-ivdr-transition,-acc Regulatory Focus en 2024-01-23 Commission proposes to extend IVDR transition, accelerate EUDAMED adoption https://www.raps.org/news-and-articles/news-articles/2024/1/pharma-industry-questions-fda-on-platform-technolo Regulatory Focus en 2024-01-23 Pharma industry questions FDA on platform technology designation program https://www.raps.org/news-and-articles/news-articles/2024/1/latin-america-roundup-colombia’s-invima-faces-crit Regulatory Focus en 2024-01-23 Latin America Roundup: Colombias INVIMA faces criticism amid HIV drug shortages, personnel shakeup https://www.raps.org/news-and-articles/news-articles/2024/1/recon-sanofi-to-buy-inhibrx-for-$2-2b;-fda-pursues Regulatory Focus en 2024-01-23 Recon: Sanofi to buy Inhibrx for 22B FDA pursues boxed warnings for CAR-T therapies https://www.raps.org/news-and-articles/news-articles/2024/1/fda-proposes-guidance-on-orthopedic-product-coatin Regulatory Focus en 2024-01-22 FDA proposes guidance on orthopedic product coatings https://www.raps.org/news-and-articles/news-articles/2024/1/growing-interest-in-modeling-prompts-launch-of-mie Regulatory Focus en 2024-01-22 Growing interest in modeling prompts launch of MIE program for generic drugs https://www.raps.org/news-and-articles/news-articles/2024/1/asia-pacific-roundup-india-approves-cooperation-ag Regulatory Focus en 2024-01-22 Asia-Pacific Roundup: India approves cooperation agreements with 3 countries https://www.raps.org/news-and-articles/news-articles/2024/1/recon-gilead’s-trodelvy-falters-in-lung-cancer-stu Regulatory Focus en 2024-01-22 Recon: Gileads Trodelvy falters in lung cancer study EMA weighs cardiovascular indications for Novos Wegovy https://www.raps.org/news-and-articles/news-articles/2024/1/fda-leaders-detail-reorg-plans,-say-1,500-ora-staf Regulatory Focus en 2024-01-19 FDA leaders detail reorg plans, say 1,500 ORA staff will be reassigned https://www.raps.org/news-and-articles/news-articles/2024/1/this-week-at-fda-shuren-pushes-for-ldt-reform,-gao Regulatory Focus en 2024-01-19 This Week at FDA: Shuren pushes for LDT reform, GAO to investigate device recalls, and more https://www.raps.org/news-and-articles/news-articles/2024/1/cdrh-record-novel-device-authorizations,-mdufa-goa Regulatory Focus en 2024-01-18 CDRH: Record novel device authorizations, MDUFA goals on track in FY2023 https://www.raps.org/news-and-articles/news-articles/2024/1/euro-roundup-ema-answers-questions-on-the-shelf-li Regulatory Focus en 2024-01-18 Euro Roundup: EMA answers questions on the shelf-life of sterile products after opening or reconstitution https://www.raps.org/news-and-articles/news-articles/2024/1/recon-fda-rejects-shin-nippon’s-nasal-migraine-dru Regulatory Focus en 2024-01-18 Recon: FDA rejects Shin Nippons nasal migraine drug over manufacturing issues GAO to review FDAs oversight of device recalls https://www.raps.org/news-and-articles/news-articles/2024/1/radiological-health-regulation-ai-x-ray Regulatory Focus en 2024-01-18 What 2 former FDA officemates wish you knew about radiological health regulation https://www.raps.org/news-and-articles/news-articles/2024/1/cder’s-office-of-compliance-highlights-enforcement Regulatory Focus en 2024-01-17 CDERs Office of Compliance highlights enforcement actions in 2023 https://www.raps.org/news-and-articles/news-articles/2024/1/ema-approved-77-drugs,-rejected-3-in-2023 Regulatory Focus en 2024-01-16 EMA recommended 77 drugs, rejected 3 in 2023 https://www.raps.org/news-and-articles/news-articles/2024/1/warning-letters-same-old,-same-old-at-fda Regulatory Focus en 2024-01-16 Warning letters: Same old, same old at FDA https://www.raps.org/news-and-articles/news-articles/2024/1/recon-allakos-cuts-its-workforce-by-50-,-halts-lea Regulatory Focus en 2024-01-16 Recon: Allakos cuts its workforce by 50, halts lead inflammatory candidate Takeda wins another FDA approval for immune globulin therapy HyQvia https://www.raps.org/news-and-articles/news-articles/2024/1/regulatory-affairs-certification-rac-info-passers Regulatory Focus en 2024-01-16 These 160 professionals earned their RAC in autumn 2023 https://www.raps.org/news-and-articles/news-articles/2024/1/swissmedic-updates-guidances-on-api,-fast-track-pa Regulatory Focus en 2024-01-15 Swissmedic updates guidances on API, fast-track pathway, and more https://www.raps.org/news-and-articles/news-articles/2024/1/who-offers-guidance-on-reducing-antimicrobial-wast Regulatory Focus en 2024-01-15 WHO offers guidance on reducing antimicrobial waste from manufacturing sites https://www.raps.org/news-and-articles/news-articles/2024/1/recon-novo-restarts-shipments-of-1-7-mg-dose-of-we Regulatory Focus en 2024-01-15 Recon: Novo restarts shipments of 17 mg dose of Wegovy in US FDA approves Mercks Keytruda combo for expanded cervical cancer use https://www.raps.org/news-and-articles/news-articles/2024/1/asia-pacific-roundup-india-opens-new-cdsco-office, Regulatory Focus en 2024-01-15 Asia-Pacific Roundup: India opens new CDSCO office, drug testing lab to improve medicine monitoring https://www.raps.org/news-and-articles/news-articles/2024/1/fda-eyes-collaborative-review-pilot-for-gene-thera Regulatory Focus en 2024-01-12 FDA eyes collaborative review pilot for gene therapies https://www.raps.org/news-and-articles/news-articles/2024/1/this-week-at-fda-bracing-for-a-shutdown,-new-chief Regulatory Focus en 2024-01-12 This Week at FDA: Bracing for a shutdown, new chief of staff, Califf at CES https://www.raps.org/news-and-articles/news-articles/2024/1/fda-updates-draft-guidance-on-division-level-anda Regulatory Focus en 2024-01-11 FDA updates draft guidance on division-level ANDA disputes https://www.raps.org/news-and-articles/news-articles/2024/1/commenters-split-on-fda’s-off-label-communication Regulatory Focus en 2024-01-11 Commenters split on FDAs off-label communication guidance https://www.raps.org/news-and-articles/news-articles/2024/1/recon-emergent-wins-$235-8m-us-anthrax-vaccine-con Regulatory Focus en 2024-01-11 Recon: Emergent wins 2358M US anthrax vaccine contract FDA allows import of syphilis drugs from France amid shortage https://www.raps.org/news-and-articles/news-articles/2024/1/euro-roundup-ema-explains-how-tweaked-brexit-deal Regulatory Focus en 2024-01-11 Euro Roundup: EMA explains how tweaked Brexit deal will affect medicinal products https://www.raps.org/news-and-articles/news-articles/2024/1/drugmakers-seek-details-on-interact-meetings Regulatory Focus en 2024-01-10 Drugmakers seek details on INTERACT meetings https://www.raps.org/news-and-articles/news-articles/2024/1/mhra-details-plans-for-future-medical-device,-ivd Regulatory Focus en 2024-01-10 MHRA details plans for future medical device, IVD regulations https://www.raps.org/news-and-articles/news-articles/2024/1/marks-discusses-car-ts,-crispr-and-start-at-regene Regulatory Focus en 2024-01-09 Marks discusses CAR-Ts, CRISPR and START at regenerative medicine meeting https://www.raps.org/news-and-articles/news-articles/2024/1/cder-notches-uptick-in-novel-drug-approvals-in-202 Regulatory Focus en 2024-01-09 CDER notches uptick in novel drug approvals in 2023 https://www.raps.org/news-and-articles/news-articles/2024/1/fda-issues-final-guidance-on-rare-disease-drug-dev Regulatory Focus en 2024-01-09 FDA issues final guidance on rare disease drug development https://www.raps.org/news-and-articles/news-articles/2024/1/recon-fda-rejects-astellas’-gastric-cancer-drug;-g Regulatory Focus en 2024-01-09 Recon: FDA rejects Astellas gastric cancer drug GSK to buy Aiolos Bio for 14B https://www.raps.org/news-and-articles/news-articles/2024/1/latin-america-roundup-argentina’s-president-names Regulatory Focus en 2024-01-09 Latin America Roundup: Argentinas president names new ANMAT director https://www.raps.org/news-and-articles/news-articles/2024/1/fda-reprimands-two-otc-drugmakers-for-inadequate-s Regulatory Focus en 2024-01-08 FDA reprimands two OTC drugmakers for inadequate screening for contaminants https://www.raps.org/news-and-articles/news-articles/2024/1/fda-updates-sterilization-category-to-encourage-va Regulatory Focus en 2024-01-08 FDA updates sterilization category to encourage vaporized hydrogen peroxide use https://www.raps.org/news-and-articles/news-articles/2024/1/recon-boston-scientific-buys-urology-devicemaker-a Regulatory Focus en 2024-01-08 Recon: Boston Scientific buys urology devicemaker Axonics for 37 billion JJ, Merck announce purchases of cancer therapy developers https://www.raps.org/news-and-articles/news-articles/2024/1/asia-pacific-roundup-tga-guidance-clarifies-medici Regulatory Focus en 2024-01-08 Asia-Pacific Roundup: TGA guidance clarifies medicinal cannabis advertising rules https://www.raps.org/news-and-articles/news-articles/2024/1/this-week-at-fda-fda-allows-florida-to-import-drug Regulatory Focus en 2024-01-05 This Week at FDA: Agency allows Florida to import drugs Biden turns to DPA to address drug shortages https://www.raps.org/news-and-articles/news-articles/2024/1/fda-considers-issuing-more-final-guidances-without Regulatory Focus en 2024-01-05 FDA considers issuing more final guidances without comment period https://www.raps.org/news-and-articles/news-articles/2024/1/gop-lawmakers-prod-fda-over-internal-scientific-di Regulatory Focus en 2024-01-04 GOP lawmakers prod FDA over internal scientific disputes resolution process https://www.raps.org/news-and-articles/news-articles/2024/1/industry-groups-seek-changes-to-fda’s-remote-inter Regulatory Focus en 2024-01-04 Industry groups seek changes to FDAs remote interactive evaluation guidance https://www.raps.org/news-and-articles/news-articles/2024/1/euro-roundup-swissmedic-reorganizes-to-clarify-med Regulatory Focus en 2024-01-04 Euro Roundup: Swissmedic reorganizes to clarify medical device and market surveillance responsibilities https://www.raps.org/news-and-articles/news-articles/2024/1/recon-novo-nordisk-signs-$1-1b-deals-with-two-biot Regulatory Focus en 2024-01-04 Recon: Novo Nordisk signs 11B deals with two biotechs for obesity drugs Health Canada approves Pfizers hemophilia B gene therapy https://www.raps.org/news-and-articles/news-articles/2024/1/fda’s-adds-microbiological-assessments-to-ophthalm Regulatory Focus en 2024-01-03 FDA adds microbiological assessments to ophthalmic drug quality guidance https://www.raps.org/news-and-articles/news-articles/2024/1/fda-issues-final-guidance-on-major-statement-dtc-a Regulatory Focus en 2024-01-03 FDA issues final guidance on major statement in DTC ads https://www.raps.org/news-and-articles/news-articles/2024/1/fda-finalizes-guidance-to-limit-use-of-benzene-in Regulatory Focus en 2024-01-02 FDA finalizes guidance to limit use of benzene in drug products https://www.raps.org/news-and-articles/news-articles/2024/1/fda-cgt-draft-guidance-focuses-on-potency-assuranc Regulatory Focus en 2024-01-02 FDA CGT draft guidance focuses on potency assurance strategy https://www.raps.org/news-and-articles/news-articles/2024/1/recon-infant-formula-recalled-for-potential-contam Regulatory Focus en 2024-01-02 Recon: Infant formula recalled for potential contamination risks Bristol Myers to acquire cancer startup RayzeBio for 41B https://www.raps.org/news-and-articles/news-articles/2023/12/this-week-at-fda-year-end-guidance-drop,-counterfe Regulatory Focus en 2023-12-22 This Week at FDA: Year-end guidance drop, counterfeit Ozempic, and more https://www.raps.org/news-and-articles/news-articles/2023/12/fda-proposes-master-control-trial-guidance-that-go Regulatory Focus en 2023-12-22 FDA proposes master control trial guidance that goes beyond COVID-19 https://www.raps.org/news-and-articles/news-articles/2023/12/impurities-in-drug-substances-and-drug-products-a Regulatory Focus en 2023-12-22 Impurities in drug substances and drug products: A regulatory CMC perspective https://www.raps.org/news-and-articles/news-articles/2023/12/stakeholders-concerned-with-fda’s-definition-of-la Regulatory Focus en 2023-12-22 Stakeholders concerned with FDAs definition of labeling in PDURS guidance https://www.raps.org/news-and-articles/news-articles/2023/12/fda-finalizes-guidances-on-rwd-in-regulatory-submi Regulatory Focus en 2023-12-21 FDA finalizes guidances on RWD in regulatory submissions, assessing registries https://www.raps.org/news-and-articles/news-articles/2023/12/fda-updates-third-party-510(k)-guidance Regulatory Focus en 2023-12-21 FDA updates third party 510k guidance https://www.raps.org/news-and-articles/news-articles/2023/12/fda-eases-informed-consent-requirements-for-minima Regulatory Focus en 2023-12-21 FDA eases informed consent requirements for minimal risk trials https://www.raps.org/news-and-articles/news-articles/2023/12/euro-roundup-mdcg-responds-to-new-questions-on-mdr Regulatory Focus en 2023-12-21 Euro Roundup: MDCG responds to new questions on MDR, IVDR rules for importers and distributors https://www.raps.org/news-and-articles/news-articles/2023/12/recon-fda-rejects-merck’s-chronic-cough-drug;-sano Regulatory Focus en 2023-12-21 Recon: FDA rejects Mercks chronic cough drug Sanofi abandons lung cancer drug after Phase III miss https://www.raps.org/news-and-articles/news-articles/2023/12/groups-seek-changes-to-fda’s-single-trial-effectiv Regulatory Focus en 2023-12-19 Groups seek changes to FDAs single-trial effectiveness guidance https://www.raps.org/news-and-articles/news-articles/2023/12/fda-proposes-updated-medtech-rwe-guidance Regulatory Focus en 2023-12-19 FDA proposes updated medtech RWE guidance https://www.raps.org/news-and-articles/news-articles/2023/12/recon-fda-approves-chiesi’s-rare-skin-disease-gel; Regulatory Focus en 2023-12-19 Recon: FDA approves Chiesis rare skin disease gel Merck snags priority review for pneumococcal jab https://www.raps.org/news-and-articles/news-articles/2023/12/study-fda-using-postmarketing-requirements-for-onc Regulatory Focus en 2023-12-19 Study: FDA using postmarketing requirements for oncology drugs more often to assess dose optimization https://www.raps.org/news-and-articles/news-articles/2023/12/latin-america-roundup-brazil-approves-skinny-label Regulatory Focus en 2023-12-19 Latin America Roundup: Brazil approves skinny labeling https://www.raps.org/news-and-articles/news-articles/2023/12/nist-drafts-differential-privacy-guidance-to-enhan Regulatory Focus en 2023-12-18 NIST drafts differential privacy guidance to enhance individual privacy in research https://www.raps.org/news-and-articles/news-articles/2023/12/eu-agencies-adopt-workplan-on-ai-in-medicines-regu Regulatory Focus en 2023-12-18 EU agencies adopt workplan on AI in medicines regulation https://www.raps.org/news-and-articles/news-articles/2023/12/asia-pacific-roundup-singapore’s-hsa-details-chang Regulatory Focus en 2023-12-18 Asia-Pacific Roundup: Singapores HSA details changes to eCTD implementation https://www.raps.org/news-and-articles/news-articles/2023/12/recon-illumina-agrees-to-divest-grail-after-antitr Regulatory Focus en 2023-12-18 Recon: Illumina agrees to divest Grail after antitrust battle Indian retailer IndiaMART working with Novo to stop illicit Wegovy sales https://www.raps.org/news-and-articles/news-articles/2023/12/this-week-at-fda-opioid-labeling-update,-reorganiz Regulatory Focus en 2023-12-15 This Week at FDA: Opioid labeling update, reorganization, and more https://www.raps.org/news-and-articles/news-articles/2023/12/mdcg-issues-guidance-for-products-without-an-inten Regulatory Focus en 2023-12-15 MDCG issues guidance for products without an intended medical purpose https://www.raps.org/news-and-articles/news-articles/2023/12/industry-groups-express-misgivings-on-fda’s-qmm-pr Regulatory Focus en 2023-12-15 Industry groups express misgivings on FDAs QMM program https://www.raps.org/news-and-articles/news-articles/2023/12/experts-expect-opponents-of-ldt-rule-to-ramp-up-co Regulatory Focus en 2023-12-14 Experts expect opponents of LDT rule to ramp up Congressional lobbying https://www.raps.org/news-and-articles/news-articles/2023/12/fda-guidance-details-new-advanced-manufacturing-te Regulatory Focus en 2023-12-14 FDA guidance details new advanced manufacturing technology designation program https://www.raps.org/news-and-articles/news-articles/2023/12/recon-senators-press-fda-on-device-oversight-after Regulatory Focus en 2023-12-14 Recon: Senators press FDA on device oversight after Philips recall White House seeks to impose inflation penalties on drugmakers https://www.raps.org/news-and-articles/news-articles/2023/12/euro-roundup-ema-answers-questions-about-raw-data Regulatory Focus en 2023-12-14 Euro Roundup: EMA answers questions about raw data pilot https://www.raps.org/news-and-articles/news-articles/2023/12/fda’s-human-foods,-regulatory-affairs-office-reorg Regulatory Focus en 2023-12-13 FDAs human foods, regulatory affairs office reorg edges forward https://www.raps.org/news-and-articles/news-articles/2023/12/eu-reveals-essential-medicines-list-to-combat-drug Regulatory Focus en 2023-12-12 EU reveals essential medicines list to combat drug shortages https://www.raps.org/news-and-articles/news-articles/2023/12/experts-discuss-red-flags-that-can-trigger-legal-a Regulatory Focus en 2023-12-12 Experts discuss red flags that can trigger legal action against drug and device makers https://www.raps.org/news-and-articles/news-articles/2023/12/recon-pfizer-to-conclude-$43b-seagen-purchase-afte Regulatory Focus en 2023-12-12 Recon: Pfizer to conclude 43B Seagen purchase after giving away cancer drug rights JJ touts phase 3 results for multiple myeloma therapy https://www.raps.org/news-and-articles/news-articles/2023/12/lopa-bakranias-full-circle-journey-into-regulator Regulatory Focus en 2023-12-12 Lopa Bakranias full-circle journey into regulatory affairs https://www.raps.org/news-and-articles/news-articles/2023/12/advamed-poaches-mita-members-and-staff-to-form-new Regulatory Focus en 2023-12-11 AdvaMed poaches MITA members and staff to form new imaging division https://www.raps.org/news-and-articles/news-articles/2023/12/asia-pacific-roundup-cdsco-advises-drugmakers-to-o Regulatory Focus en 2023-12-11 Asia-Pacific Roundup: CDSCO advises drugmakers to only use pharma-grade excipients from approved sources https://www.raps.org/news-and-articles/news-articles/2023/12/recon-eu-sets-comprehensive-rules”-governing-ai;-b Regulatory Focus en 2023-12-11 Recon: EU eyes new rules governing AI Bluebirds newly approved sickle cell gene therapy priced at 22M https://www.raps.org/news-and-articles/news-articles/2023/12/this-week-at-fda-biden-administration-turns-to-mar Regulatory Focus en 2023-12-08 This Week at FDA: Biden administration turns to march-in rights to combat high drug prices https://www.raps.org/news-and-articles/news-articles/2023/12/fall-unified-agenda-includes-new-rule-on-removing Regulatory Focus en 2023-12-08 Fall unified agenda includes new rule on removing outdated regulations, returning QMSR and LDT rules https://www.raps.org/news-and-articles/news-articles/2023/12/fda-finalizes-guidance-on-dscsa-verification-syste Regulatory Focus en 2023-12-08 FDA finalizes guidance on DSCSA verification systems https://www.raps.org/news-and-articles/news-articles/2023/12/rf-quarterly,-december-2023-raps-convergence Regulatory Focus en 2023-12-08 RF Quarterly, December 2023: RAPS Convergence https://www.raps.org/news-and-articles/news-articles/2023/12/pediatric-drug-development Regulatory Focus en 2023-12-08 Pediatric drug development: Essential insights for success https://www.raps.org/news-and-articles/news-articles/2023/12/facilitating-self-directed-care-the-fda-s-proposed Regulatory Focus en 2023-12-08 Facilitating self-directed care: The FDAs proposed ACNU rule https://www.raps.org/news-and-articles/news-articles/2023/12/clinical-evidence-under-the-eu-mdr-a-notified-body Regulatory Focus en 2023-12-08 Clinical evidence under the EU MDR: A notified body perspective https://www.raps.org/news-and-articles/news-articles/2023/12/drug-device-combination-products-device-regulatory Regulatory Focus en 2023-12-08 Drug-device combination products: Device regulatory submission content and considerations https://www.raps.org/news-and-articles/news-articles/2023/12/seven-attributes-for-success-as-a-regulatory-leade Regulatory Focus en 2023-12-08 Seven attributes for success as a regulatory leader https://www.raps.org/news-and-articles/news-articles/2023/12/fda-compliance-chiefs-detail-fy2023-trends,-plans Regulatory Focus en 2023-12-07 FDA compliance chiefs detail FY2023 trends, plans for FY2024 https://www.raps.org/news-and-articles/news-articles/2023/12/experts-fda’s-project-jurisdiction-officers-are-ke Regulatory Focus en 2023-12-07 Experts: FDAs Product Jurisdiction Officers are key resources in developing combo products https://www.raps.org/news-and-articles/news-articles/2023/12/combination-products-fda-experts-address-udi,-harm Regulatory Focus en 2023-12-07 Combination products: FDA experts address UDI, harmonization, OPQ reorganization https://www.raps.org/news-and-articles/news-articles/2023/12/euro-roundup-ema-identifies-need-to-‘streamline’-p Regulatory Focus en 2023-12-07 Euro Roundup: EMA identifies need to streamline processes in wake of COVID-19 pandemic https://www.raps.org/news-and-articles/news-articles/2023/12/recon-biden-administration-exercises-authority-to Regulatory Focus en 2023-12-07 Recon: Biden administration exercises authority to seize certain drug patents Abbvie buys neuro developer Cerevel for 87B https://www.raps.org/news-and-articles/news-articles/2023/12/fda-ramps-up-routine-surveillance-inspections,-gra Regulatory Focus en 2023-12-07 FDA ramps up routine surveillance inspections, grapples with backlog https://www.raps.org/news-and-articles/news-articles/2023/12/fda’s-lack-of-onsite-inspections-may-have-compromi Regulatory Focus en 2023-12-05 FDAs lack of onsite inspections may have compromised drug quality, study says https://www.raps.org/news-and-articles/news-articles/2023/12/recon-fda-steps-ahead-of-partner-nations-in-approv Regulatory Focus en 2023-12-05 Recon: FDA steps ahead of partner nations in approving six cancer drugs under Project Orbis BIO names John Crowley as new CEO https://www.raps.org/news-and-articles/news-articles/2023/12/latin-america-roundup-paho-director-defends-mexico Regulatory Focus en 2023-12-05 Latin America Roundup: PAHO director defends Mexicos COVID-19 vaccine policy https://www.raps.org/news-and-articles/news-articles/2023/12/cber-chief-says-pilot-program-will-justify-increas Regulatory Focus en 2023-12-04 CBER chief says pilot program will justify increasing reviewer headcount https://www.raps.org/news-and-articles/news-articles/2023/12/fda-slaps-intas-with-another-warning-letter;-warns Regulatory Focus en 2023-12-04 FDA warning letters address CGMP, clinical study plan failures https://www.raps.org/news-and-articles/news-articles/2023/12/recon-roche-to-buy-obesity-drugmaker-carmot-therap Regulatory Focus en 2023-12-04 Recon: Roche to buy obesity drugmaker Carmot Therapeutics for 27B Supreme Court hears oral arguments in Purdue bankruptcy case https://www.raps.org/news-and-articles/news-articles/2023/12/asia-pacific-roundup-tga-quarantines-products-over Regulatory Focus en 2023-12-04 Asia-Pacific Roundup: TGA quarantines products over potential bacterial contamination https://www.raps.org/news-and-articles/news-articles/2023/12/this-week-at-fda-bumpus-moves-up,-congress-stalls, Regulatory Focus en 2023-12-01 This Week at FDA: Bumpus moves up, Congress stalls, and CDRH withdraws from GHWP https://www.raps.org/news-and-articles/news-articles/2023/12/president-biden-announces-new-focus-on-supply-chai Regulatory Focus en 2023-12-01 President Biden announces new focus on supply chain security with creation of new cabinet council https://www.raps.org/news-and-articles/news-articles/2023/12/device-cybersecurity-must-be-a-priority-from-desig Regulatory Focus en 2023-12-01 Device cybersecurity must be a priority from design through retirement, experts say https://www.raps.org/news-and-articles/news-articles/2023/11/mdcg-raises-alarm-over-lack-of-mdr,-ivdr-applicati Regulatory Focus en 2023-11-30 MDCG raises alarm over lack of MDR, IVDR applications https://www.raps.org/news-and-articles/news-articles/2023/11/euro-roundup-romanian-senate-pushes-back-against-e Regulatory Focus en 2023-11-30 Euro Roundup: Romanian Senate pushes back against EU plans to change duration of market exclusivity https://www.raps.org/news-and-articles/news-articles/2023/11/recon-abbvie-purchases-immunogen-for-$10-billion-t Regulatory Focus en 2023-11-30 Recon: AbbVie purchases Immunogen for 10 billion to boost cancer portfolio Cigna and Humana merger talks underway https://www.raps.org/news-and-articles/news-articles/2023/11/fda-investigates-risk-of-secondary-malignancies-wi Regulatory Focus en 2023-11-30 FDA investigates risk of secondary malignancies with CAR T-cell therapy https://www.raps.org/news-and-articles/news-articles/2023/11/bumpus-propelled-to-fda’s-second-in-command Regulatory Focus en 2023-11-29 Bumpus propelled to FDAs second-in-command https://www.raps.org/news-and-articles/news-articles/2023/11/combination-products-non-harmonized-regulations-ar Regulatory Focus en 2023-11-29 Combination products: Non-harmonized regulations are hurting manufacturers https://www.raps.org/news-and-articles/news-articles/2023/11/fda-pulls-out-of-medtech-forum-over-divergent-pers Regulatory Focus en 2023-11-28 FDA pulls out of medtech forum over divergent perspectives https://www.raps.org/news-and-articles/news-articles/2023/11/fda-outlines-process-for-recognizing-standards-for Regulatory Focus en 2023-11-28 FDA outlines process for recognizing standards for regenerative medicines https://www.raps.org/news-and-articles/news-articles/2023/11/fda-warns-cipla-over-poor-contamination-controls-a Regulatory Focus en 2023-11-28 FDA warns Cipla over poor contamination controls and minimizing problems tied to defective inhalers https://www.raps.org/news-and-articles/news-articles/2023/11/recon-fda-approves-springworks’-ogsiveo-for-treati Regulatory Focus en 2023-11-28 Recon: FDA approves SpringWorks Ogsiveo for treating desmoid tumors Pfizer sues Poland over missed COVID-19 vaccine payments https://www.raps.org/news-and-articles/news-articles/2023/11/recon-novo-nordisk-pays-$2-4-billion-to-build-fren Regulatory Focus en 2023-11-27 Recon: Novo Nordisk pays 24B to build French plant for GLP-1 drugs production UK names synthetic opioids to its banned drugs list https://www.raps.org/news-and-articles/news-articles/2023/11/tcet-pathway-may-broaden-access-to-breakthrough-de Regulatory Focus en 2023-11-27 TCET pathway may broaden access to breakthrough devices, but reforms still needed https://www.raps.org/news-and-articles/news-articles/2023/11/pharma-groups-fight-proposed-ban-on-titanium-dioxi Regulatory Focus en 2023-11-27 Pharma groups fight proposed ban on titanium dioxide in Europe https://www.raps.org/news-and-articles/news-articles/2023/11/asia-pacific-roundup-australia’s-tga-adds-adverse Regulatory Focus en 2023-11-27 Asia-Pacific Roundup: Australias TGA adds adverse event search feature in response to feedback https://www.raps.org/news-and-articles/news-articles/2023/11/existing-software-development-lifecycle-tools-can Regulatory Focus en 2023-11-24 Existing software development lifecycle tools can help speed AIML products to market https://www.raps.org/news-and-articles/news-articles/2023/11/expert-‘one-does-not-just-walk-into-mordor-and-get Regulatory Focus en 2023-11-21 Expert: One does not just walk into Mordor and get a PCCP https://www.raps.org/news-and-articles/news-articles/2023/11/stakeholders-urge-fda-to-retain-interchangeability Regulatory Focus en 2023-11-21 Stakeholders urge FDA to retain interchangeability statements on biosimilar labeling https://www.raps.org/news-and-articles/news-articles/2023/11/recon-european-patent-office-invalidates-moderna-m Regulatory Focus en 2023-11-21 Recon: European Patent Office invalidates Moderna mRNA patent Nvidia and Genentech ink AI deal https://www.raps.org/news-and-articles/news-articles/2023/11/fda-issues-new-standards-for-dtc-prescription-drug Regulatory Focus en 2023-11-21 FDA issues new standards for DTC prescription drug ads https://www.raps.org/news-and-articles/news-articles/2023/11/latin-america-roundup-el-salvador-merges-regulator Regulatory Focus en 2023-11-21 Latin America Roundup: El Salvador merges regulatory branches to create super-agency https://www.raps.org/news-and-articles/news-articles/2023/11/providing-context-to-ai-ml-products-may-address-ex Regulatory Focus en 2023-11-20 Providing context to AIML products may address explainability says FDA https://www.raps.org/news-and-articles/news-articles/2023/11/new-report-offers-roadmap-for-fda-to-rebuild-publi Regulatory Focus en 2023-11-20 New report offers roadmap for FDA to rebuild public trust https://www.raps.org/news-and-articles/news-articles/2023/11/recon-medtronic-wins-fda-nod-for-hypertension-devi Regulatory Focus en 2023-11-20 Recon: Medtronic wins FDA nod for hypertension device despite expert panel misgivings FDA lists recall of B Braun Medical pump system as Class I https://www.raps.org/news-and-articles/news-articles/2023/11/asia-pacific-roundup-malaysia’s-npra-updates-regul Regulatory Focus en 2023-11-20 Asia-Pacific Roundup: Malaysias NPRA updates regulatory reliance guide, expands pool of reference agencies https://www.raps.org/news-and-articles/news-articles/2023/11/the-eu-clinical-trials-regulation-–-experiences-fr Regulatory Focus en 2023-11-17 The EU Clinical Trials Regulation Experiences from the first 18 months https://www.raps.org/news-and-articles/news-articles/2023/11/this-week-at-fda-woodcock’s-irreplaceable-legacy-a Regulatory Focus en 2023-11-17 This Week at FDA: Woodcocks irreplaceable legacy and an averted shutdown https://www.raps.org/news-and-articles/news-articles/2023/11/legacy-devices-report-highlights-need-for-data-to Regulatory Focus en 2023-11-17 Legacy devices report highlights need for data to support future policies https://www.raps.org/news-and-articles/news-articles/2023/11/fda-publishes-final-guidances-on-device-shortage-r Regulatory Focus en 2023-11-17 FDA publishes final guidances on device shortage reporting, computational modeling https://www.raps.org/news-and-articles/news-articles/2023/11/fda-global-pharma’s-eye-drops-contaminated-with-fi Regulatory Focus en 2023-11-17 FDA: Global Pharmas eye drops contaminated with filth while Amazon made unapproved claims for eye drops https://www.raps.org/news-and-articles/news-articles/2023/11/recon-china-us-health-regulatory-dialogue-at-biden Regulatory Focus en 2023-11-16 Recon: China-US health regulatory dialogue at Biden-Xi summit Pan-EU launch requirement could bring challenges https://www.raps.org/news-and-articles/news-articles/2023/11/euro-roundup-medtech-europe-warns-data-act-poses-‘ Regulatory Focus en 2023-11-16 Euro Roundup: MedTech Europe warns Data Act poses highly complex challenges for health sector https://www.raps.org/news-and-articles/news-articles/2023/11/studies-drugmakers-are-gaming-the-patent-system-wi Regulatory Focus en 2023-11-16 Studies: Drugmakers are gaming the patent system with misrepresentations, ancillary patents https://www.raps.org/news-and-articles/news-articles/2023/11/industry-calls-for-revisions-in-fda’s-cgt-manufact Regulatory Focus en 2023-11-16 Industry calls for revisions in FDAs CGT manufacturing change guidance https://www.raps.org/news-and-articles/news-articles/2023/11/stakeholders-not-working-together-to-develop-ai-st Regulatory Focus en 2023-11-15 Stakeholders not working together to develop AI standards, expert laments https://www.raps.org/news-and-articles/news-articles/2023/11/doctors’-groups-share-concerns-about-fda-draft-gui Regulatory Focus en 2023-11-15 Doctors groups share concerns about FDA draft guidances for developing weight-loss devices https://www.raps.org/news-and-articles/news-articles/2023/11/medtech-expert-says-eu’s-ai-act-could-face-an-uphi Regulatory Focus en 2023-11-14 Medtech expert says EUs AI Act could face an uphill political battle https://www.raps.org/news-and-articles/news-articles/2023/11/experts-call-for-data-transparency-with-recalled-m Regulatory Focus en 2023-11-14 Experts call for data transparency with recalled medical devices https://www.raps.org/news-and-articles/news-articles/2023/11/recon-uk-nice-to-help-sponsors-navigate-hta-proces Regulatory Focus en 2023-11-14 Recon: UK NICE to help sponsors navigate HTA process FDA flexes new authority to assess delayed confirmatory trials for cancer drugs https://www.raps.org/news-and-articles/news-articles/2023/11/fda-announces-opq-reorganization-to-alleviate-‘lon Regulatory Focus en 2023-11-13 FDA announces OPQ reorganization to alleviate long-standing pain points https://www.raps.org/news-and-articles/news-articles/2023/11/recon-astrazeneca-priorities-us-market-for-rsv-dru Regulatory Focus en 2023-11-13 Recon: AstraZeneca priorities US market for RSV drug Japan to ease rules on testing new drugs overseas https://www.raps.org/news-and-articles/news-articles/2023/11/asia-pacific-roundup-india-and-the-netherlands-agr Regulatory Focus en 2023-11-13 Asia-Pacific Roundup: India and the Netherlands agree to cooperate on medical product regulation https://www.raps.org/news-and-articles/news-articles/2023/11/fda-highlights-updated-labeling-for-some-surgical Regulatory Focus en 2023-11-13 FDA highlights updated labeling for some surgical mesh products, cautions against use of mesh in breast surgery https://www.raps.org/news-and-articles/news-articles/2023/11/this-week-at-fda-government-shutdown-looms-again Regulatory Focus en 2023-11-10 This Week at FDA: Government shutdown looms again, COVID-19 enforcement policies end https://www.raps.org/news-and-articles/news-articles/2023/11/ema-plans-major-revamp-of-regulatory-website Regulatory Focus en 2023-11-10 EMA plans major revamp of regulatory website https://www.raps.org/news-and-articles/news-articles/2023/11/ema-announces-first-drugs-to-publish-epi-that-can Regulatory Focus en 2023-11-10 EMA announces first drugs to publish ePI that can be used across member states https://www.raps.org/news-and-articles/news-articles/2023/11/ftc-puts-10-drugmakers-on-notice-for-orange-book-p Regulatory Focus en 2023-11-09 FTC puts 10 drugmakers on notice for Orange Book patent violations https://www.raps.org/news-and-articles/news-articles/2023/11/recon-eli-lilly-wins-fda-nod-for-obesity-therapy-z Regulatory Focus en 2023-11-09 Recon: Eli Lilly wins FDA nod for obesity therapy Zepbound Fully synthetic genome nears completion https://www.raps.org/news-and-articles/news-articles/2023/11/euro-roundup-efpia-warns-pharma-legislation-could Regulatory Focus en 2023-11-09 Euro Roundup: EFPIA warns pharma legislation could slash global RD over next 15 years https://www.raps.org/news-and-articles/news-articles/2023/11/the-subjectivity-of-starting-materials-in-the-era Regulatory Focus en 2023-11-08 The subjectivity of starting materials in the era of harmonization https://www.raps.org/news-and-articles/news-articles/2023/11/ich-adopts-guidelines-on-viral-safety-evaluation-a Regulatory Focus en 2023-11-08 ICH adopts guidelines on viral safety evaluation and analytical method development https://www.raps.org/news-and-articles/news-articles/2023/11/fda-finalizes-guidance-on-real-time-review-of-onco Regulatory Focus en 2023-11-07 FDA finalizes guidance on real-time review of oncology drugs https://www.raps.org/news-and-articles/news-articles/2023/11/fda-recognizes-three-new-international-medical-dev Regulatory Focus en 2023-11-07 FDA recognizes three new international medical device software security standards https://www.raps.org/news-and-articles/news-articles/2023/11/recon-senate-confirms-monica-bertagnolli-as-nih-di Regulatory Focus en 2023-11-07 Recon: Senate confirms Monica Bertagnolli as NIH director Sen Sanders pushes for hearing with top pharma executives https://www.raps.org/news-and-articles/news-articles/2023/11/latin-america-roundup-longtime-pharma-critic-named Regulatory Focus en 2023-11-07 Latin America Roundup: Longtime pharma critic named head of Colombias INVIMA https://www.raps.org/news-and-articles/news-articles/2023/11/fda-publishes-two-guidances-on-collecting-clinical Regulatory Focus en 2023-11-06 FDA publishes two guidances on collecting clinical outcomes data https://www.raps.org/news-and-articles/news-articles/2023/11/perspective-fda-moving-in-the-right-direction-with Regulatory Focus en 2023-11-06 Perspective: FDA moving in the right direction with psychedelic drug guidance https://www.raps.org/news-and-articles/news-articles/2023/11/recon-drugmakers-to-increase-adderall-output-to-co Regulatory Focus en 2023-11-06 Recon: Drugmakers to increase Adderall output to combat US shortage EUs proposed legislation may hurt pharma innovation https://www.raps.org/news-and-articles/news-articles/2023/11/asia-pacific-roundup-india-seeks-feedback-on-harmo Regulatory Focus en 2023-11-06 Asia-Pacific Roundup: India seeks feedback on harmonization plan https://www.raps.org/news-and-articles/news-articles/2023/11/fda-ramps-up-monitoring-in-high-risk-areas-followi Regulatory Focus en 2023-11-06 FDA ramps up monitoring in high-risk areas following DEG-contamination deaths overseas https://www.raps.org/news-and-articles/news-articles/2023/11/this-week-at-fda-agency-won’t-extend-ldt-rule-comm Regulatory Focus en 2023-11-03 This Week at FDA: Agency wont extend LDT rule comment period, drops new guidances, and schedules meetings https://www.raps.org/news-and-articles/news-articles/2023/11/fda-warns-two-companies-over-cgmp-deviations,-devi Regulatory Focus en 2023-11-03 FDA warns two companies over CGMP deviations, device violations https://www.raps.org/news-and-articles/news-articles/2023/11/fda-reiterates-guidance-plans-on-distributed-and-p Regulatory Focus en 2023-11-03 FDA reiterates guidance plans on distributed and point-of-care manufacturing https://www.raps.org/news-and-articles/news-articles/2023/11/fda-extends-regulatory-flexibilities-for-pma,-hde Regulatory Focus en 2023-11-02 FDA extends regulatory flexibilities for PMA, HDE modifications https://www.raps.org/news-and-articles/news-articles/2023/11/recon-cber-chief-said-fda’s-confidence-in-gene-edi Regulatory Focus en 2023-11-02 Recon: CBER chief said FDAs confidence in gene editing is growing Belgium confiscates counterfeit weight-loss drugs https://www.raps.org/news-and-articles/news-articles/2023/11/euro-roundup-uk-regulators-to-create-a-‘sandbox’-f Regulatory Focus en 2023-11-02 Euro Roundup: UK regulators to create a sandbox for AI development EMA eliminates delay in publishing clinical trials data https://www.raps.org/news-and-articles/news-articles/2023/11/interpol,-global-regulators-seize-$7-million-worth Regulatory Focus en 2023-11-02 Interpol, global regulators seize 7 million worth of counterfeit drugs https://www.raps.org/news-and-articles/news-articles/2023/11/fda-notes-continued-growth”-of-orbis-collaborative Regulatory Focus en 2023-11-01 FDA notes continued growth of Orbis collaborative review program, adds EMA as observer https://www.raps.org/news-and-articles/news-articles/2023/10/the-emerging-transparency-paradigm-for-clinical-tr Regulatory Focus en 2023-10-31 The emerging transparency paradigm for clinical trials in Europe https://www.raps.org/news-and-articles/news-articles/2023/10/fda-won’t-extend-ldt-rule-comment-period Regulatory Focus en 2023-10-31 FDA wont extend LDT rule comment period https://www.raps.org/news-and-articles/news-articles/2023/10/fda-expands-kasa-review-program-to-drug-substances Regulatory Focus en 2023-10-31 FDA expands KASA review program to drug substances https://www.raps.org/news-and-articles/news-articles/2023/10/notified-body-perspective-evaluating-uses-for-real Regulatory Focus en 2023-10-31 Notified body perspective: Evaluating uses for real-world data https://www.raps.org/news-and-articles/news-articles/2023/10/recon-gsk-to-pay-$1-billion-for-exclusive-rights-t Regulatory Focus en 2023-10-31 Recon: GSK to pay 1 billion for exclusive rights to hepatitis B drug Another Finnish notified body designated under IVDR https://www.raps.org/products/choosing-the-right-regulatory-career 2026-01-05T14:03:11-05:00 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