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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.

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.

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.

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

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products authorized in the European Union or United States.

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 device regulation, and what we’re reading from around the web. Multiple outlets reported that FDA Commissioner Marty Makary is being pushed out at FDA, though it is unclear how or when the departure will take place.

LISBON – Regulators and industry representatives highlighted the importance of simplifying regulations to promote innovation at the RAPS Euro Convergence 2026 conference closing plenary; however, they cautioned that oversimplification could backfire and lead to more regulation down the road.

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.