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.
Zogenix resubmits an NDA for Fintepla (fenfluramine hydrochloride) for treating seizures associated with Dravet syndrome.
Federal Register notice: FDA makes available a draft guidance on medical device regulatory electronic submissions.
CDER director Janet Woodcock says Congress has approved the Centers reorganization plan and it is being implemented.