Regulatory Affairs Professionals Society

FDA and the medtech industry have reached agreement on several key areas as they negotiate the next iteration of the Medical Device User Fee Amendments (MDUFA VI) program. hubs.la/Q047j8JL0

FDA has finalized guidance for manufacturers on using physicochemical and structural (Q3) characterization studies to establish bioequivalence in abbreviated new drug applications or topical medications. hubs.la/Q047j6Xt0

It can be challenging to fully understand the role of the PRRC. This interactive workshop will discuss the role of the PRRC & the different challenges they face. Article 15 & the connected parts of the MDR/IVDR will also be covered. Save your seat: hubs.la/Q047l6590

In their second article from the March issue of the Journal of Regulatory Affairs, Attrayee Chakraborty and Geethapriya Setty identify key implementation gaps and propose ways manufacturers can operationalize EU AI Act obligation : hubs.la/Q046Hszy0

AGG will host and sponsor the @RAPSorg Atlanta Chapter Annual Breakfast with FDA on March 20. FDA officials will discuss compliance trends affecting pharma, biologics, and medical devices. Register to hear the latest insights from industry professionals. agg.com/news-insights/…

Last month, FDA and the pharmaceutical industry concluded a series of subgroup meetings toward the reauthorizing the Prescription Drug User Fee Program (PDUFA VII). hubs.la/Q0475f_20

AI tools in clinical practice should have an oversight framework that resembles how human clinicians are trained and certified, with continuous learning, regular assessments, and supervised practice, experts argued in a recent JAMA Health Forum article. hubs.la/Q0475vWr0

Vinay Prasad, director of FDA's Center for Biologics Evaluation and Research, is leaving the agency for a second time at the end of April. Sign up for RF Today to get This Week at FDA in your inbox every Friday: hubs.la/Q046V2KQ0

FDA has finalized guidance to assist sponsors developing medical devices intended for weight loss at the premarket stage. hubs.la/Q046HP3B0

The European Medicines Agency has published a document detailing its methodology for monitoring potential vulnerabilities in the medicine supply chains. hubs.la/Q046wvwH0

In the Journal of Regulatory Affairs, Attrayee Chakraborty and Geethapriya Setty examine the shifting regulatory terrain shaped by the EU MDR and the EU AI Act, highlighting points of convergence and divergence: hubs.la/Q046HpV70

The European Medicines Agency’s Network Data Steering Group has released a joint workplan outlining a strategy for leveraging AI and big data over the next two years to expedite the approval of new medicines. hubs.la/Q046wt_g0

FDA announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the move would modernize adverse event reporting systems and provide more transparency. hubs.la/Q046wtCN0

What are the most common GMP violations FDA cites in inspection reports? An FDA official detailed the top deviations identified in Form 483 inspections at 50th International GMP Conference : hubs.ly/Q046lXDN0

FDA sent a warning letter to Novo Nordisk at its Plainsboro, NJ, site this week for a raft of postmarketing adverse drug experience violations. hubs.la/Q046wGJn0

FDA official offers insights on agency’s criteria for RWD in regulatory submissions hubs.ly/Q046lGbD0

This is a 4-session certificate program for regulatory professionals who want to step into more visible, influential roles. Plus, these expert speakers are eager to meet you starting on 27 March. Sign up today: hubs.la/Q046pLDh0

FDA has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice inspection. Until now, the FDA has not provided specific guidelines on how to respond to a Form 483. hubs.la/Q046lNK70

The transformation of drug development is moving at record speed. Join us for this interactive half-day workshop. Get your questions answered about the scientific and regulatory framework for biomarker-driven drug development. Save your spot today: hubs.la/Q046rj5K0

👏These professionals can now add RCC next to their name: hubs.la/Q046mBfj0 Congratulations to the newest Regulatory Compliance Certification (RCC) holders, all of whom have demonstrated their mastery of European medical device or IVD regulations!