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Following the completion of a new generative AI pilot for scientific reviewers, the U.S. Food and Drug Administration (FDA) announced an aggressive timeline to scale the use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025. The agency found that the generative AI tools enable FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow the review process.
To reflect the urgency of this effort, all FDA centers have been directed 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.
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 the specific needs of each center, while maintaining strict information security and compliance with FDA policy.
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.
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