By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration ...
Join RAPS Southern California, IPM, and Intertek for Connected Health at a Crossroads: Devices, Data, and Convergence, an evening of networking and thought-provoking discussion with MedTech leaders ...
This webinar will make the case for a global, holistic framework that captures overlapping and interdependent obligations through a coordinated strategy. Learn why managing trial disclosure by country ...
An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for wound ...
The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...
Three regulatory affairs professionals have been recognized as the 2026 RAPS Fellows. Each year, our society honors a new class of RAPS Fellows for their noteworthy and sustained leadership ...
The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement. FDA issued an ...
The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better ...
The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) ...
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