FDA publishes a draft guidance on incorporating voluntary patient preference information in medical device total life cycle regulatory decisions.
Federal Register notice: FDA sends to OMB an information collection reinstatement entitled Yale-Mayo Clinic Centers of Excellence in Regulatory Scienc...
Abbott Diabetes Care recalls (Class 1) three lots of its FreeStyle Libre 3 sensors after finding that a small number of them may provide incorrect hig...
FDA says a July Medtronic recall of some McGrath MAC Video Laryngoscopes due to potential battery problems is Class 1.
The Justice Department says Glenmark Pharmaceuticals, a generic drug manufacturer in Mahwah, NJ, will pay $25 million to resolve civil claims involvin...
Breas Medical recalls (Class 1) its Vivo 45 LS ventilators to update the use instructions after internal testing identified the potential for a short-...
Eli Lilly says data from two Phase 3 clinical trials evaluating once-weekly insulin efsitora alfa in adults with Type 2 diabetes showed non-inferiorit...
An Associated Press analysis says FDA is overdue on some 2,000 drug company facilities that havent been inspected since before the Covid-19 pandemic.
