The Antidepressant Coalition for Education petitions FDA to change labeling for selective serotonin reuptake inhibitors and serotonin-norepinephrine r...
FDA expands its approval of Bayers Jivi for the routine prophylactic treatment of hemophilia A in previously treated adult and pediatric patients aged...
FDAs Oncologic Drugs Advisory Committee says there are insufficient number of U.S.-treated patients in a clinical trial supporting a supplemental BLA ...
Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User...
Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years 2028 ...
FDA warns Netherlands-based NWL Netherlands Services about CGMP violations in its production of finished drugs.
FDA publishes 34 new and 14 revised product-specific guidances to aid in generic drug development.
FDA names Elizabeth Miller acting associate commissioner of the Office of Inspections and Investigations (OII), replacing Michael Rogers, who retired ...
