A panel of European regulators answered questions during a town panel discussion at RAPS Euro Convergence 2026 on the ...
The International Medical Device Regulators Forum (IMDRF) has released a guidance for manufacturers on how to choose, ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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, ...
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products ...
The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...
Industry representatives, patients, and regulators shared their perspectives on the reforms to the EU pharmaceutical ...
The US Food and Drug Administration (FDA) has finalized guidance to assist sponsors in evaluating drug safety during ...
Orphan medical device makers should be deliberate in their questions to expert panels and ensure their post-market clinical ...
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