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Federal Register notice: FDA makes available a draft guidance entitled Advanced Manufacturing Technologies Designation Program.[ Price : $8.95]
Federal Register notice: FDA creates the Genetic Metabolic Diseases Advisory Committee to review and make recommendations on inves...[ Price : $8.95]
FDA says HHS has started reviewing the agencys proposed reorganization for a unified Human Foods Program and a revised Office of R...[ Price : $8.95]
The Senate HELP Committee passes legislation giving FDA additional authority to deny opioid analgesic NDAs.[ Price : $8.95]
Nine Republican senators press FDA to increase its foreign inspections of medical product manufacturing facilities.[ Price : $8.95]
FDA accepts for priority review an Amgen BLA for tarlatamab for treating certain adult patients with advanced small cell lung canc...[ Price : $8.95]
AdvaMed faults FDA for not approving an extension to the comment deadline on three 510(k) guidances issued in September concerning...[ Price : $8.95]
Syndax Pharmaceuticals plans an NDA submission by year end for revumenib, a first-in-class menin inhibitor for treating patients w...