FDA warns Sun Pharmaceuticals about CGMP violations and other issues in its production of finished drugs in Gujarat, India.
Federal Register notice: FDA announces the continuation of its Model-Informed Drug Development Paired Meeting Program as part of the recent user fee r...
Federal Register notice: FDA corrects a 12/13/2022 notice entitled Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal.
CDER Office Medication Error Prevention and Risk Management director Claudia Manzo describes the change in REMS format to SPL.
FDA posts a six-item Form FDA-483 that cites analytical laboratory Valisure over deficient laboratory practices after a 5/26-7/6/22 agency inspection....
Writing in a JAMA Viewpoint, CDER director Peter Marks et al say that continuing to develop variant-specific vaccine boosters is inadequate as a long-...
Spectrum Laboratory Products recalls three lots of epinephrine (L-adrenaline) USP due to product discoloration complaints.
Two AI experts say there should be new baseline performance standards incorporated in algorithms that are submitted to FDA for review, as protection a...
