A panel of experts at RAPS Euro Convergence 2026 discussed how artificial intelligence (AI) is being applied throughout the ...
The European Parliament and Council have reached a provisional agreement on the Critical Medicines Act (CMA), moving ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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 ...
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 ...
Orphan medical device makers should be deliberate in their questions to expert panels and ensure their post-market clinical ...
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