Archive for December 2023

A newly published Q&A document from the FDA and the European Medicines Agency (EMA) outlines the similarities — and differences — in the two agencies’ requirements for manufacturing breakthrough products. Source: Drug Industry Daily

The FDA has smacked Fresenius Kabi with a warning letter for selling adulterated devices that fail to conform to current good manufacturing practice (cGMP) requirements, following an inspection of the devicemaker’s Waltham, Mass., facility from June 26 to Aug. 2. Source: Drug Industry Daily

A recently approved position paper from the European Association of Medical Devices Notified Bodies — referred to as Team-NB — addresses the question “What should ‘lifetime’ mean in guidelines when referring to the lifespan of medical devices?” Source: Drug Industry Daily

In this edition of Quick Notes, we look at FDA breakthrough designation for a pulsed ablation system for treatment of atrial fibrillation, an implant to treat glaucoma and ocular hypertension, a label expansion for a game-based digital therapeutic device for adolescents with ADHD, and an antigen test to detect the presence of a cancer-causing bacteria.…

In a final guidance issued this week, the FDA outlines recommendations for continued development of monoclonal antibody products targeting SARS-CoV-2 to meet emergency needs. Source: Drug Industry Daily

Olympus Corporation of the America’s recall of 17,691 bronchofiberscopes and bronchovideoscopes due to burn and fire hazards has been identified as a Class I recall. Source: Drug Industry Daily

Upcoming events in the coming weeks and months include two FDA advisory committee meetings; and MAGI 2024: The Clinical Research Conference in New Orleans, and an FDAnews sponsored webinar on manufacturing medical devices with AI-integrated QMS. Source: Drug Industry Daily

This edition of Quick Notes looks at new M&A rules, a long overdue separation, conference room procedures, and prescription opioid labeling. Source: Drug Industry Daily

Apple is pausing U.S. sales of its new Series 9 and Ultra 2 Apple watches due to a dispute with Masimo, a monitoring technologies medtech company, that alleges certain Apple watches violate its heart rate and blood oxygen monitor patents. Source: Drug Industry Daily

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published an AI workplan intended to create a collaborative and coordinated strategy that will maximize AI’s benefits while managing the risks. Source: Drug Industry Daily