Regulatory Focus

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. This week, a drug safety group filed a citizen petition with FDA opposing the marketing of unapproved compounded peptides, a bipartisan bill was introduced to reform clinical trial participation and review, and more.

The US Food and Drug Administration (FDA) sent warning letters to two major healthcare product manufacturers—Baxter International and Olympus Medical Systems—for good manufacturing practice (GMP) and Quality System Regulation (QSR) violations.

The European Medicines Agency (EMA) is holding a consultation into the methodological aspects of confirmatory platform clinical trials.

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

Major pharmaceutical companies are urging the US Food and Drug Administration (FDA) to adopt a more flexible, risk-based approach in its guidance on testing container-closure systems (CCS) for drugs and biological products, especially when established materials and technologies are used.

BOSTON – Top US Food and Drug Administration (FDA) medical device officials said they are focused on restaffing after last year’s reduction-in-force (RIF) and are optimistic about the Medical Device User Fee Amendments (MDUFA VI) agreement during a town hall panel at The MedTech Conference.

Boston – Regulators from the US and UK discussed ongoing efforts to develop regulatory frameworks that are better suited to generative artificial intelligence (genAI) products at The MedTech Conference on Tuesday.

The US Food and Drug Administration (FDA) on Tuesday finalized guidance to address how sponsors can develop, distribute, and label software applications (apps) used alongside prescription medicines. These can include apps that are used with asthma inhalers or stand-alone symptom trackers, dose reminders, or health coaching tools.