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An FDA inspection of Colchester, VT-based Edge Pharma ends in a 17-page Form FDA 483 that cites numerous GMP deficiencies.[ Price : $8.95]
Federal Register notice: FDA announces 11/16 virtual public meeting entitled Potential Approach for Ranking of Antimicrobial Drugs...[ Price : $8.95]
FDA issues Avenue Therapeutics a complete response letter due to safety concerns on its NDA for intravenous tramadol, indicated fo...[ Price : $8.95]
FDA approves Alexion Pharmaceuticals Ultomiris (ravulizumab-cwvz) 100 mg/mL, a new dosing formulation for treating adults with par...[ Price : $8.95]
FDA clears a GE Healthcare 510(k) for the Ultra Edition package on its Vivid cardiovascular ultrasound systems, which includes new...[ Price : $8.95]
FDA accepts for review a Foresee Pharmaceuticals 505(b)(2) NDA for Camcevi 42mg, a ready-to-use six-month depot formulation of leu...[ Price : $8.95]
FDA grants Beckman Coulter an emergency use authorization for its Access SARS-CoV-2 Immunoglobulin M (IgM) assay.[ Price : $8.95]
FDA issues a revised Manual of Policies and Procedures on ANDA Suitability Petitions to clarify certain issues and include minor u...