Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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Officials from the US Food and Drug Administration (FDA) discussed the launch of a new artificial intelligence (AI) system to consolidate 40 different application data sources across all centers at the Food and Drug Law Institute’s (FDLI) Annual Meeting on Thursday.
LISBON – Orphan medical device makers should be deliberate in their questions to expert panels and ensure their post-market clinical follow-up (PMCF) plan is realistic, according to experts who spoke at RAPS Euro Convergence 2026 on Thursday.