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 ...
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 ...
RAPS

Southern California LNG In Person Event: Connected Health at a Crossroads: Devices, Data, and Convergence

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 ...
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 ...
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 ...
Regulatory Affairs Professionals Society

Recon: FDA denies Hengrui-Elevar liver cancer drug for the third time; GSK to pursue FDA nod for Jemperli for rectal cancer

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

Asia-Pacific Roundup: India cuts prices of more than 30 drugs and biologics

India’s National Pharmaceutical Pricing Authority (NPPA) has announced price reductions for more than 30 drugs and biological ...
RAPS

Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drug

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 ...