Regulatory Affairs Professionals Society

FDA recently issued warning letters to drugmakers in Japan and the US, as well as a producer of active pharmaceutical ingredients based in India, citing the firms for violations of current good manufacturing practice. hubs.la/Q04j0pt50

Pharmaceutical industry groups say they support FDA draft guidance on new approach methodologies (NAM), which aims to replace animal testing with innovative models, such as in silico modeling, to assess drug safety. hubs.la/Q04hSKVC0

The European Medicines Agency, in partnership with the European Commission, and the Heads of Medicines Agencies, has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area. hubs.la/Q04hv12H0

An agency official presented three case studies demonstrating how sponsors effectively utilized real-world evidence and real-world data to secure approval for their products at FDA's Regulatory Education for Industry (REdI) meeting this week: hubs.la/Q04htR970

FDA has issued warning letters to two researchers for failing to meet good clinical practice requirements and for not complying with their own trial protocols. hubs.la/Q04hv1vB0

#RAPS50For50 celebrates Kate Stockman, who just finished playing a crucial role at #RAPSEuroConvergence 2026! Learn more about Kate and see how you can nominate someone here: hubs.la/Q04hqSYG0

PhRMA said FDA's recent draft guidance on marketing exclusivity for new clinical investigations provides essential clarity on the types of applications that are eligible for the incentive. However, both PhRMA and Novartis said clarification is necessary. hubs.la/Q04h5GFj0

A panel of experts at #RAPSEuroConvergence discussed how AI is being applied throughout the product lifecycle, from compiling premarket application submissions to assisting in the conduct of conformity assessments. hubs.la/Q04h5BJF0

FDA is asking for input on repurposing older drugs for new therapeutic uses to address unmet medical needs across a wide range of therapeutic areas. hubs.la/Q04gMXLQ0

A panel of European regulators answered questions during a town panel discussion at #RAPSEuroConvergence on the implementation of the new EU Pharmaceutical Legislation and the use of AI in regulatory and drug development. Read their takeaways: hubs.la/Q04gMXW_0

The top observations identified in Form 483 reports from inspections conducted under the recently implemented QMSR include risk management, outsourcing and purchasing, and complaint handling and feedback, an FDA's official says. hubs.la/Q04gMFnS0

FDA has released a final guidance document with immediate effect advising sponsors on chemistry, manufacturing, and controls flexibilities for cell and gene therapy products developed for biologics license applications. hubs.la/Q04g4f2d0

Come read a RAPS member-exclusive chapter of our new book and share your takeaways with other RAPS members! Regulatory Reading Club is back: hubs.la/Q04gDtwZ0

Explore the the transition from the EU IVDD, under which notified bodies conducted device verification using various alternative methods, to the EURL legal framework established under EU IVDR, Article 100: hubs.la/Q04gDk4n0

Regulators and industry representatives highlighted the importance of simplifying regulations to promote innovation at the #RAPSEuroConvergence closing plenary. hubs.la/Q04g4b6_0

Angelina Lisandrelli has served the regulatory affairs profession as an accomplished medical device expert, volunteer, and mentor. We are proud to celebrate her as part of #RAPS50for50! Learn more about Angelina here: hubs.ly/Q04gvtwH0

Orphan medical device makers should be deliberate in their questions to expert panels and ensure their PMCF plan is realistic, according to experts who spoke at #RAPSEuroConvergence. hubs.la/Q04g4gq60

FDA Commissioner Marty Makary is leaving the agency, President Donald Trump confirmed to reporters. He also announced on Truth Social that Kyle Diamantas, who currently serves as FDA deputy commissioner for food, will step up as acting FDA commissioner. hubs.la/Q04gkJBj0

FDA has announced a new pilot program promising one-day inspections for low-risk facilities. The program will use AI to identify facilities for these abridged inspections, which FDA Commissioner Marty Makary touted as a “safety screening." hubs.la/Q04g47wq0

A panel of experts representing regulators, industry, and notified bodies gave their opinions on the proposed revision of the EU MDR at #RAPSEuroConvergence: hubs.la/Q04g4hVz0