Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2023.
Researchers say Congress should consider giving FDA more authority to deal with companies that dont complete their postmarket commitments on time, inc...
FDA publishes two final guidances to facilitate the timely start and finish of medical device post-approval studies and postmarket surveillance.
FDA approves a Roche PMA for the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast cancer patients with low...
Federal Register notice: FDA announces a 12/14 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Viatris Specialty supplemental N...
Federal Register notice: FDA announces a 12/13 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Cytokinetics NDA for omecamtiv me...
FDA publishes a guidance with updated GDUFA 3 information on information requests and discipline review letters.
FDA publishes a guidance with information on competitive generic therapies.
