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, ...
The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. I ...
The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.
Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the time ...
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 ...
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 ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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