In a historic first for the agency, FDA Commissioner Dr. Martin A. Makary, M.D., M.P.H., announced an ambitious plan to implement artificial intelligence (AI) across all FDA centers by June 30, 2025. This follows the successful completion of a new generative AI pilot program designed 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 emphasize the urgency of this initiative, Dr. Makary has instructed all FDA centers to commence deployment immediately, aiming for full integration by the end of June. After June 30, efforts will continue to expand use cases, enhance functionality, and adapt to the evolving needs of each center. By that date, all centers will be operating on a common, secure generative AI system that is 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
The FDA is planning to enhance its generative AI capabilities across all centers by implementing a secure, unified platform. Future improvements will aim to increase usability, broaden document integration, and customize outputs to meet the specific needs of each center, all while ensuring strict adherence to information security and compliance with FDA policies.
The agency-wide rollout is being coordinated by Jeremy Walsh, the FDA’s newly appointed Chief AI Officer, along with Sridhar Mantha. Walsh has a background in leading large-scale technology deployments across federal health and intelligence agencies, while Mantha recently headed the Office of Business Informatics at CDER.
The agency will assess performance, gather user feedback, and refine features to support FDA staff and its public health mission. More updates will be shared in June.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
