Federal Register notice: FDA makes available a draft guidance entitled Advanced Manufacturing Technologies Designation Program.
Federal Register notice: FDA creates the Genetic Metabolic Diseases Advisory Committee to review and make recommendations on investigational or market...
FDA says HHS has started reviewing the agencys proposed reorganization for a unified Human Foods Program and a revised Office of Regulatory Affairs.
The Senate HELP Committee passes legislation giving FDA additional authority to deny opioid analgesic NDAs.
Nine Republican senators press FDA to increase its foreign inspections of medical product manufacturing facilities.
FDA accepts for priority review an Amgen BLA for tarlatamab for treating certain adult patients with advanced small cell lung cancer.
AdvaMed faults FDA for not approving an extension to the comment deadline on three 510(k) guidances issued in September concerning the 2018 Medical De...
Syndax Pharmaceuticals plans an NDA submission by year end for revumenib, a first-in-class menin inhibitor for treating patients with relapsed/refract...
