The European Parliament and Council have reached a provisional agreement on the Critical Medicines Act (CMA), moving ...

The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and ...

The US Food and Drug Administration (FDA) is asking for input on repurposing older drugs for new therapeutic uses to address unmet medical needs across a wide range of therapeutic areas. FDA said that ...

Get a preview of this year’s RAPS Convergence, hosted by a special panel of peers who have the behind-the-scenes details to get you ready — and excited — for Charlotte. Get a behind-the-scenes look at ...

President Donald Trump on Tuesday confirmed that Marty Makary, Commissioner of the US Food and Drug Administration (FDA), is leaving the agency. He also announced on Truth Social that Kyle Diamantas, ...

The International Medical Device Regulators Forum (IMDRF) has released a guidance for manufacturers on how to choose, ...

A panel of European regulators answered questions during a town panel discussion at RAPS Euro Convergence 2026 on the ...

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

The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products ...

Officials from the US Food and Drug Administration (FDA) discussed the launch of a new artificial intelligence (AI) system to ...

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 ...