RAPS

North Carolina LNG In Person Event- Inside FDA ASCA: Practical Insights

The RAPS NC Local Networking Group presents an in-person FDA ASCA Program session focused on the appropriate use of standards, conformity assessment, and practical strategies for premarket submissions ...
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

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

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 ...
RAPS

News & Insights Search

Each year, our society honors a new class of RAPS Fellows for their noteworthy and sustained leadership contributions to their organizations, to RAPS, and to the regulatory affairs profession. Each ...
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

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

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

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 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 ...
RAPS

Recon: Novo sues Lilly over weight-loss drug ads; Gilead, Merck say HIV pill keeps HIV suppressed in two Phase 3 trials

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top ...
RAPS

Study: China outpaces the US in cancer approvals, lags behind on first approvals

While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more first ...