The U.S. Food and Drug Administration plans to integrate generative artificial intelligence across all its centers by June 30, 2025, following a successful pilot program.
Here are five things to know:
- The pilot program used generative AI tools to assist scientific reviewers, with the goal of reducing repetitive tasks and streamlining the agency’s review process for new therapies, according to a May 8 news release.
- The FDA said the tools have significantly accelerated scientific review tasks. Jinzhong Liu, deputy director of the Office of Drug Evaluation Sciences within the Center for Drug Evaluation and Research, said the new technology has reduced the time required for certain review tasks from three days to minutes.
- FDA Commissioner Martin Makary, MD, has directed all agency centers to begin deploying the AI system immediately to meet the June 2025 deadline.
- Each center will be operating on a shared, secure generative AI platform integrated with the agency’s internal data systems by the end of June 2025.
- Future plans include improving usability, integrating more documents and customizing tools for each center’s unique needs while maintaining strict information security standards. The FDA will continue collecting user feedback and expects to release another public update in June.