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Federal Register notice: FDA seeks comments on an information collection extension for Testing Communications on Medical Devices a...[ Price : $8.95]
A new Government Accountability Office report finds that generic drug companies are having mixed results from FDAs efforts to help...[ Price : $8.95]
FDAs Endocrinologic and Metabolic Diseases Advisory Committee unanimously votes to recommend approval for Amarins submission to ex...[ Price : $8.95]
FDA clears a Pentax 510(k) for the first duodenoscope with a sterile, disposable elevator component that the agency says will redu...[ Price : $8.95]
FDA approves a Novartis BLA for Adakveo (crizanlizumab-tmca) for reducing the frequency of vaso-occlusive crisis in sickle cell di...[ Price : $8.95]
FDA approves a Shionogi & Co. NDA for Fetroja (cefiderocol), an antibacterial drug for treating patients 18 years of age or older ...[ Price : $8.95]
FDA funds a $1.7 million two-year project in which five universities will study quality management in FDA drug manufacturing opera...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Process to Request a Review of FDAs Decision Not to Issue C...