A new online commentary by two CDER Office of Medical Policy officials outlines the advantages and challenges of conducting decentralized clinical tri...
Federal Register notice: FDA announces a 3/15 Oncologic Drugs Advisory Committee meeting to discuss sBLAs for Janssens Carvykti and Celgenes Abecma.
Seven former FDA commissioners file an amicus brief with the Supreme Court urging that a lower court ruling restricting access to the abortion drug mi...
FDA Commissioner Robert Califf says artificial intelligence (AI) embedded in clinical decision support or the integration of AI into clinical practice...
The Center for Veterinary Medicine issues two guidances on data element submission.
FDA says NeuroBo can start a Phase 1 trial of its DA-1726 weight loss drug.
Former FDA deputy commissioner Deborah M. Autor joins consulting group Healthcare Innovation Catalysts as chief executive officer.
FDA accepts for priority review an Adaptimmune Therapeutics BLA for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarc...
