Curated Regulatory Intelligence Augmented by AI
Medical Devices
The Italian Medicines Agency (AIFA) recently published news regarding a new document ‘Questions & Answers...
US FDA recently released the draft guidance on decentralized clinical trials and has also scheduled...
The Food and Drug Administration (FDA Philippines) published news regarding guidelines about relying on the...
The U.S. Food and Drug Administration (FDA) proposed draft guidance that contains its recommendations for...
Taiwan FDA published new law on Electronic Manuals replacing Chinese Manuals for Medical Devices. ...
US FDA proposed draft guidance titled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints...
The U.S. Food and Drug Administration (FDA) proposed a draft guidance document that provides recommendations...
Indonesia Ministry of Health published news regarding The Draft Health Law is a Solution for...
The final transition guidances provide recommendations and clarity for medical device manufacturers that may or...
This document supersedes Assembler’s guide to diagnostic x-ray equipment: responsibilities of assemblers, distributors, and dealers...
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