Insider Brief
- The FDA is rolling out generative AI tools across all centers by June 30, 2025, to streamline scientific reviews and reduce administrative workload.
- A successful pilot program showed that generative AI could significantly cut time spent on routine tasks like summarizing trial data and scanning regulatory documents.
- The agency will use a unified, secure platform tailored to each center’s needs, with oversight from its new Chief AI Officer and continued updates based on staff feedback.
After FDA Commissioner Martin A. Makary reported being “blown away” by initial tests of generative AI in the scientific review process, The U.S. Food and Drug Administration is moving to integrate generative artificial intelligence tools across all of its centers by June 30, 2025, marking the first time the agency has coordinated a full-scale deployment of AI to support regulatory science.
The move follows a pilot program involving FDA scientific reviewers, who used generative AI to automate routine documentation and analysis tasks. The FDA said the technology helped reduce the time spent on repetitive work, freeing up experts to focus on evaluating the safety and efficacy of new medical products. In response to the pilot’s results, Makary directed each FDA center to begin implementation immediately, with the goal of full integration by the end of June.
“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 effort is being led by Chief AI Officer Jeremy Walsh and Sridhar Mantha, a longtime leader in FDA’s digital infrastructure. According to the agency, the program is designed to enhance the speed and consistency of internal reviews while maintaining compliance with its strict security and data governance policies.
“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).
All centers are expected to migrate to a single, secure generative AI system tied into FDA’s existing internal data platforms. This system will allow users across different regulatory units to apply generative AI to a wide range of tasks—from summarizing clinical trial data to scanning regulatory documents for relevant precedents. The FDA emphasized that the rollout would be phased and iterative, with continued improvements based on staff input and operational feedback.
By implementing the same generative AI platform across its various divisions, including those regulating drugs, medical devices, biologics, and food safety, the FDA aims to improve workflow efficiency and coordination between scientific reviewers and regulatory managers.
“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.
Beyond the June 2025 deadline, the FDA plans to extend the system’s capabilities, focusing on usability, the integration of additional internal documents, and the ability to tailor AI-generated outputs to the unique needs of each center. Future iterations may also expand the types of data the AI can process and summarize, though the agency underscored that all uses will be governed by FDA policy and security standards.
This agency-wide push signals a broader shift in how federal health regulators view artificial intelligence—not as a regulatory target, but as a practical tool to enhance oversight and operational performance. The FDA said further details and public updates will be provided in June.
