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) 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 ...
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products ...
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 ...
Officials from the US Food and Drug Administration (FDA) discussed the launch of a new artificial intelligence (AI) system to ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Regulators and industry representatives highlighted the importance of simplifying regulations to promote innovation at the ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results