Regulatory Focus

LISBON – A panel of experts at RAPS Euro Convergence 2026 discussed how artificial intelligence (AI) is being applied throughout the product lifecycle, from compiling premarket application submissions to assisting in the conduct of conformity assessments.

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 purchasing, and complaint handling and feedback.

The European Parliament and Council have reached a provisional agreement on the Critical Medicines Act (CMA), moving proposals designed to tackle shortages of key medicines closer to law.

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The International Medical Device Regulators Forum (IMDRF) has released a guidance for manufacturers on how to choose, evaluate, and monitor suppliers throughout the life cycle of medical devices.

LISBON – A panel of European regulators answered questions during a town panel discussion at RAPS Euro Convergence 2026 on the implementation of the new EU Pharmaceutical Legislation and the use of artificial intelligence (AI) in regulatory and drug development.

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, who currently serves as FDA deputy commissioner for food, will step up as acting FDA commissioner.

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.