SheppardMullin attorneys review FDA 2022 actions in several regulatory areas and look ahead to 2023.
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.
