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Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Studies and Clinical Trials: Determining Good...[ Price : $8.95]
FDA approves a Gilead Sciences supplemental NDA for the use of Veklury (remdesivir) in Covid-19 patients with severe renal impairm...[ Price : $8.95]
FDA publishes a draft guidance on managing manufacturing changes for human cellular and gene therapy products.[ Price : $8.95]
FDA approves a Laboratoire HRA Pharma (recently acquired by Perrigo) NDA to move its contraceptive Opill (norgestrel) tablet from ...[ Price : $8.95]
FDA accepts for review a Dr. Reddys Laboratories BLA for its proposed biosimilar rituximab (Genentechs Rituxan) candidate.[ Price : $8.95]
FDA publishes a draft guidance with information on how it determines good cause for noncompliance with prescription drug section 5...[ Price : $8.95]
Federal Register notice: FDA withdraws its 1/25 debarment of former Aegerion Pharmaceuticals sales representative Mark Moffett bec...[ Price : $8.95]
Federal Register notice: FDA announces a 9/20 Pediatric Advisory Committee meeting to discuss artificial womb technology devices.