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Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. In major news this week, FDA is facing two high-profile departures, beginning with the resignation of FDA Commissioner Marty Makary, who stepped down on Tuesday after just one year in office.

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.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

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.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

LISBON – Industry representatives, patients, and regulators shared their perspectives on the reforms to the EU pharmaceutical legislation at RAPS Euro Convergence 2026. The panelists noted that many challenges remain as lawmakers and regulators work to implement the law but expressed hope that it will bring much-needed improvements to the EU regulatory system.

The US Food and Drug Administration (FDA) has finalized guidance to assist sponsors in evaluating drug safety during pregnancy after a drug has been approved. The purpose of these safety studies is to gather information that can be included in drug labeling, which will help healthcare providers and patients make informed decisions.