GenAI to be rolled out across all FDA centers
Prompted by the completion of a new generative AI (genAI) pilot, the US FDA (MD, USA) has issued a timeline to scale the use of AI across all FDA centers.
FDA Commissioner Martin Makary has circulated a timeline to scale the use of AI internally across all FDA centers by the end of June 2025, following the launch of a pilot program using genAI 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,” Makary explained. “The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.”
FDA centers will 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 this date. By June 30, 2025, all centers will be operating on a common, secure genAI system integrated with the FDA’s internal data platforms. The genAI tools will allow FDA scientists and subject matter experts to spend less time on repetitive tasks that often decelerate the review process.
Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER), commented:
“This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take 3 days.”
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Looking ahead, the FDA plans to expand genAI 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 plans to release more information about the adoption initiative in June.
