Ultragenyx Pharmaceutical has agreed to pay $6 million to resolve allegations that it caused the submission of false claims to Medicare and Medicaid, according to the Department of Justice (DOJ).…

CDER has developed a new adaptive crossover trial design that can be used in demonstrating the bioequivalence (BE) of generic versions of drugs with high pharmacokinetic (PK) variability. Source: Drug…

The FDA may allow third-party 510(k) reviews for Emergency Use Authorization (EUA) requests, according to a new draft guidance. Source: Drug Industry Daily

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.…

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…