FDA Announces Aggressive Timeline for Use of Generative AI Across All Centers by End of June

The FDA has announced an “aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.”

FDA commissioner Martin Makary said that the implementation of the AI-generated scientific review pilot will “reduce the amount of non-productive busywork that has historically consumed much of the review process.” Makary “directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June. Work will continue to expand use cases, improve functionality, and adapt to the evolving needs of each center after June 30.”

The FDA also plans to “expand generative AI capabilities—across all centers using a secure, unified platform. Future enhancements will focus on improving usability, expanding document integration, and tailoring outputs to center-specific needs, while maintaining strict information security and compliance with FDA policy.”

Axios reported on reactions from those across the industry about the news. Former FDA commissioner Robert Califf said he has “enthusiasm tempered by caution about the timeline” to implement generative AI at the FDA. Mike Hinckle, an FDA compliance expert at K&L Gates, said that pharmaceutical companies will likely question “how the proprietary data they submit will be secured.” Eric Topol, founder of the Scripps Research Translational Institute, said that “the idea is good, but the lack of details and the perceived ‘rush’ is concerning.”