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 ...
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 ...
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 ...
RAPS

Why quality issues keep coming back — and how to stop them for good

Recurring quality issues can feel like ghosts. You close a corrective and preventive action (CAPA), but then a few months later, the issue returns. While closing a CAPA proves the team completed a ...
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

Austria LNG Virtual Event: MDR 2.0: Understanding the What, Why, How, When, Where, and Who

The European Medical Device Regulation (MDR) continues to evolve, and discussions around the Commission proposdal (so-called) “MDR 2.0” highlight the need for ongoing adaptation by manufacturers, ...
RAPS

Regulatory Compliance Certification (RCC)

Validate your Knowledge. Boost your Impact. The Regulatory Compliance Certification (RCC) validates your EU MDR or IVDR knowledge and elevates your credibility in an environment where Europe’s ...