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The FDA FY 2023 drug and medical device establishment inspection report lists registered establishments and inspections by type an...[ Price : $8.95]
FDA says a 4/1 Philips Respironics recall revising the use instructions for its OmniLab Advanced+ ventilator is Class 1.[ Price : $8.95]
FDA clears a Subtle Medical 510(k) for its SubtleSYNTH, which uses deep learning to generate synthetic Short Tau Inversion Recover...[ Price : $8.95]
FDA gives Sellas Life Sciences Group a Rare Pediatric Disease Designation for SLS009, a highly selective CDK9 inhibitor for treati...[ Price : $8.95]
Federal Register notice: FDA announces that Argenxs supplemental NDA for Vyvgart Hytrulo for treating chronic inflammatory demyeli...[ Price : $8.95]
FDA warns Chinas YangZhou SuXiang Medical Instrument Co. about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA warns Chinas Jiangsu Hengrui Pharmaceuticals about CGMP violations in its manufacturing of finished drugs[ Price : $8.95]
FDA publishes a guidance on how it calculates combination product application user fees.