The U.S. Food and Drug Administration (FDA) Commissioner has announced a bold timeline to deploy artificial intelligence tools across all FDA centers by June 30. 

FDA Commissioner Martin A. Makary, M.D., M.P.H., has ordered all centers to begin immediate deployment, aiming for full integration of a secure, unified generative AI system. The effort marks a shift from theoretical discussions to actionable implementation.

The announcement follows the agency’s successful pilot of generative AI for scientific review tasks.

“I was blown away by the success of our first AI-assisted scientific review pilot. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” Dr. Makary said.

The AI tools, designed to automate repetitive and time-consuming tasks, have already shown significant impact. Jinzhong (Jin) Liu, Deputy Director at FDA’s Center for Drug Evaluation and Research, called the technology “a game-changer”, saying tasks that previously took days can now be completed in minutes.

The agency-wide rollout is being coordinated by newly appointed FDA Chief AI Officer Jeremy Walsh.