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Industry groups and legal experts want the US Food and Drug Administration (FDA) to make significant revisions to a proposed guidance on how pharmaceutical manufacturers should address Form 483 observations after a current good manufacturing practice (CGMP) inspection.

The Pharmaceutical Research and Manufacturers of America (PhRMA) said the US Food and Drug Administration’s (FDA) recent draft guidance on marketing exclusivity for new clinical investigations provides essential clarity on the types of applications that are eligible for the incentive. However, both PhRMA and Novartis highlighted that additional clarification is still necessary on some topics.

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

Australia’s Therapeutic Goods Administration (TGA) has released guidance on manufacturing, supplying, and advertising compounded medicines to support compliance with its regulatory requirements.

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.