The FDA has successfully completed its first AI-assisted scientific review pilot, marking a significant milestone. FDA Commissioner Martin A. Makary, M.D., M.P.H., announced an ambitious plan to integrate artificial intelligence (AI) across all FDA centers by June 30, 2025. This initiative aims to streamline processes and reduce the time scientists spend on repetitive tasks. According to Deputy Director Jinzhong (Jin) Liu, these tools have drastically cut down review times from days to mere minutes. The deployment will begin immediately, with full integration expected by the end of June 2025. Following this deadline, all centers will operate on a unified, secure AI system. Dr. Makary emphasized the importance of action over discussion, highlighting the potential to significantly enhance efficiency in therapeutic reviews. Future steps include expanding AI capabilities, ensuring security, and tailoring solutions to meet center-specific needs. The FDA’s Chief AI Officer, Jeremy Walsh, and Sridhar Mantha are leading this effort, which will continue to evolve based on feedback and performance assessments. — new from fda.gov
