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FDA warns Gilbert, AZ-based Suretec Innovations about CGMP and drug listing violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA warns Dayton, NJ-based Safrel Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA issues a complete response letter to Xspray Pharmas NDA for Dasynoc, raising issues about a third-party manufacturer.[ Price : $8.95]
FDA grants Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and child...[ Price : $8.95]
Academic researchers worldwide say FDA and other regulators must approve artificial intelligence/machine learning-enabled devices ...[ Price : $8.95]
FDA approves Regnerons Pasatru (garetosmab-grts) for reducing new heterotopic ossification (bone formation outside the skeleton) i...[ Price : $8.95]
FDA releases a draft guidance that outlines recommendations for developing potency assays for active immunotherapy products, inclu...[ Price : $8.95]
FDA warns Pomona, CA-based K.C. Pharmaceuticals about repeat CGMP violations in the production of over-the-counter drugs.