Regulatory Affairs Professionals Society

FDA advisory committee backs two controversial peptides

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 ...
Regulatory Affairs Professionals Society

Recon: J&J nabs FDA authorization for general surgery robot; FDA urged to ban DTC drug ads

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. I ...
Regulatory Affairs Professionals Society

Euro Roundup: EMA seeks feedback on planned changes to guidance on biosimilar efficacy studies

The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.
Regulatory Affairs Professionals Society

European Commission publishes guideline on transparency obligations under AI Act

The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) ...
RAPS

FDA issues untitled letters to Sanofi and Viatris for false advertising

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 ...
Regulatory Affairs Professionals Society

FDA proposes rule to ease registration for distributed manufacturers, require foreign API sites to register

The US Food and Drug Administration (FDA) on Friday outlined a set of proposed reforms to advance modern manufacturing ...
RAPS

MDCG: Only manufacturers should assign UDI-DIs

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 ...
RAPS

This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, and more

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, ...
RAPS

Experts: Ending adequate provision would shut down prescription drug ads

The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the high ...
Regulatory Affairs Professionals Society

FDA admonishes companies for marketing unauthorized products, making misleading claims

The US Food and Drug Administration (FDA) recently issued two warning letters to companies for marketing medical devices ...
RAPS

CDER plans new guidance on AI, electronic safety report submissions, and more

CDER plans new guidance on AI, electronic safety report submissions, and more FDA headquarters in White Oak, Md. (Credit: Ferdous Al-Faruque) The US Food and Drug Administration’s (FDA) Center for ...