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# FDA Implementing AI-Assisted Scientific Review
- URL: https://www.fdaweb.com/fda-implementing-ai-assisted-scientific-review/
- Published: 2025-05-08T12:00:00.000Z
- Updated: 2026-09-14T15:11:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Biologics, Drugs, Devices, #legacy-id-D5159144

FDA commissioner **Michael Makary** says the agency will expand the use of artificial intelligence (AI)-assisted scientific reviews across all Centers by 6/30\. In a [statement](https://www.fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai?ref=fdaweb.com), he says the rollout follows the successful 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,” Makary said. “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.”

The statement says all Centers have been directed to begin deployment immediately, with a goal of full integration by 6/30\. It says work will continue to expand use cases, improve functionality, and adapt to the evolving needs of each Center after 6/30\. It is anticipated that by the goal date, all Centers will be operating on a common, secure, generative AI system integrated with the agency’s internal data platforms, it says.

Future enhancements, the statement says, 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.