The U.S. Food and Drug Administration (FDA) has announced an aggressive plan to fully integrate generative AI across its centers by June 30, 2025. Following a successful pilot of AI for scientific review processes, the FDA is now set to deploy AI tools agency-wide. This move aims to reduce non-productive tasks and accelerate the approval timeline for new therapies.
FDA Commissioner, Martin A. Makary, praised the success of the AI pilot, noting it has significantly sped up tasks that previously took days, with some scientific reviews now completed in minutes instead of three days.
Key Highlights:
- Generative AI to be fully integrated by June 30, 2025.
- Pilot project success: Reducing review time from 3 days to minutes.
- Future plans: Expanding AI use to improve document integration, usability, and customization for different centers.
Makary emphasized that it’s time to act on AI promises, marking a critical shift from years of discussions to real-world application.
For the full article, refer to FDA AI Adoption Initiative.