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

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 ...
RAPS

FDA draft guidance sets impurity controls for most antibiotics

The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for antibiotics produced through fermentation or semi-synthetic methods. This guidance ...
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

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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 ...
RAPS

Journal of Regulatory Affairs

Welcome to the latest issue of the RAPS Journal of Regulatory Affairs, an independent research-based publication building on the success of the former, RF Quarterly. This member-exclusive journal ...
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 ...
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

FDA cites companies for CGMP violations, informed consent failure

The US Food and Drug Administration has issued warning letters to several drug makers for failing to meet its current good manufacturing practices (CGMP) requirements and a company for failing to ...