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…
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…
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,…
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…
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…
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…
Despite overall industry support for the FDA’s development of a voluntary Quality Management Maturity (QMM) program for establishments manufacturing drugs, stakeholders raised concerns about a lack of details and the…