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 ...
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

Introducing 2 new FRA credentials in global regulatory strategy

Launched in 2025, the FRA is an assessment-based certificate designed to help those new regulatory affairs or those seeking to transition into the field. Building on this foundation, RAPS is ...
Regulatory Affairs Professionals Society

MDUFA VI: Draft commitment letter details enhancements, performance goals

The US Food and Drug Administration (FDA) and the medtech industry have agreed to commitment letter language for the Medical ...
Regulatory Affairs Professionals Society

FDA plans rules to rein in drug ads, enable proactive release of CRLs, and more

The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to ...
RAPS

Recon: White House reviewing 3 candidates for FDA chief; GSK exits Alector deal after Alzheimer’s, dementia flops

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 ...
RAPS

Tampons: FDA toxicological study finds negligible levels of toxic metals

Researchers at the US Food and Drug Administration (FDA) recently conducted a study in response to a 2024 study that raised safety concerns about metal toxicity from tampons; however, the study found ...
Regulatory Affairs Professionals Society

Recon: Novartis to acquire Myricx Bio for $1.1B; Republican lawmakers press FDA to ensure trials are diverse

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
RAPS

Euro Roundup: Committee warns ‘overly expansive’ MDR interpretation could undermine access to cell and tissue products

A Council of Europe committee has warned that “an overly expansive interpretation” of the Medical Device Regulation (MDR) could undermine access to therapies based on human blood, tissues, and cells.
Regulatory Affairs Professionals Society

Euro Roundup: Notified bodies propose changes to Commission plan for risk-adaptive device surveillance

Notified body association Team-NB has suggested changes to the European Commission’s proposals for risk-adaptive surveillance ...