Per the notice below, the United States Food and Drug Administration (FDA) is highlighting its use of artificial intelligence (AI) in its regulatory review process.

FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline

In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today 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.

“I was blown away by the success of our first AI-assisted scientific review pilot.  We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process.  The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” said Dr. Makary.

The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.

“This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,” said Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER).

To reflect the urgency of this effort, Dr. Makary has 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.  By that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.

“There have been years of talk about AI capabilities in frameworks, conferences and panels but we cannot afford to keep talking.  It is time to take action.  The opportunity to reduce tasks that once took days to just minutes is too important to delay,” said Dr. Makary.

Next Steps

Looking ahead, the FDA 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.  The agency-wide rollout is being coordinated by Jeremy Walsh, the FDA’s newly appointed Chief AI Officer and Sridhar Mantha.  Walsh previously led enterprise-scale technology deployments across federal health and intelligence agencies and Mantha recently led the Office of Business Informatics in CDER.  The agency will continue to assess performance, gather user feedback and refine features to support the evolving needs of FDA staff and advance its public health mission.  Additional details and updates on the initiative will be shared publicly in June.