By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, ...
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 ...
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. Last revised in 2015, the guideline outlines ...
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 ...
RAQA Leadership Retreat 2026 Join the RAPS Switzerland Chapter RAQA Leadership Retreat 2026 in the Swiss Alps for two days of expert-led discussions, peer exchange, and practical insights designed for ...
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 ...