Regulatory Focus

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.

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

BOSTON – Despite some early jitters, the medtech industry is coming around to the Quality Management System Regulation (QMSR), according to a top industry executive who spoke at The MedTech Conference on Monday.