CDERs Office of Prescription Drug Promotion cites a Kowa Pharmaceuticals America direct-to-consumer patient testimonial video montage about cholestero...
Federal Register notice: FDA makes available a draft guide on demonstrating bioequivalence for soluble powder oral dosage form products and Type A med...
Federal Register notice: FDA makes available a draft guidance entitled Clinical Decision Support Software.
FDA awards a new five-year contract to enhance its Sentinel System and prepare it for managing real-world data to improve the safety and effectiveness...
FDA approves Genentechs Rituxan (rituximab) injection to treat granulomatosis with polyangiitis and microscopic polyangiitis in children two years of ...
An email distribution by Galt Pharmaceuticals to health professionals draws an FDA Warning Letter on insomnia drug Doral (quazepam) tablets because it...
Federal Register notice: FDA announces a 10/31 public meeting on an International Council on Harmonization guideline on clinical trial considerations.
FDA issues new and updated guidances to clarify regulatory oversight of various digital health tools.