Glenmark Pharmaceuticals recalls (Class 1) 114 batches of potassium chloride extended-release capsules, USP (750 mg), due to dissolution concerns.
A House subcommittee report claims that FDA cut corners in its usually rigorous processes and bowed to Biden Administration political pressure in appr...
FDA sends AbbVie a second complete response letter on its NDA for ABBV-951 (for carbidopa/foslevodopa) for treating motor fluctuations in adults with ...
Federal Register notice: FDA makes available a final guidance entitled Laboratory Developed Tests (LDTs): Small Entity Compliance Guide.
FDA accepts for review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) in combination with sertraline for treati...
FDA releases a guidance entitled Laboratory Developed Tests: Small Entity Compliance Guide.
FDA approves an Endotronix PMA for its Cordella Pulmonary Artery Sensor System for treating New York Heart Failure Class III heart failure patients.
The House Energy and Commerce Committee seeks additional inspection records from FDA after its analysis of the foreign drug inspection program found t...
