Federal Register notice: FDA seeks interested industry organizations to participate in selecting a nonvoting industry representative to serve on CBER ...
Federal Register notice: FDA posts a list of seven information collections that have been recently approved by OMB.
FDA accepts an Alnylam Pharmaceuticals NDA for givosiran for treating acute hepatic porphyria.
FDA says its FY 2018 PMR/PMC performance report shows that the majority of post-marketing requirements and commitments were successfully completed or ...
FDA accepts a Rockwell Medical NDA an intravenous formulation of Triferic (ferric pyrophosphate citrate) for kidney disease patients.
FDA clears an Mt. Derm 510(k) to expand the use of its Exceed microneedling device for treating acne scarring.
FDA warns Results RNA about CGMP violations in its production of finished drugs.
FDA praises a DC federal court decision backing the way the agency determines clinical need for bulk drug substances to be compounded by outsourcing f...