News Brief: Successful AI Pilot Prompts FDA to Launch Full-Scale Integration

FDA Commisoner Martin A. Makary, MD, MPH, announced on May 8, 2025 an “aggressive” timeline to scale use of artificail intelligence internally across all FDA centers by June 30, 2025. This follows the completion of a new generative AI pilot for scientific reviewers.

Makary highlighted the transformative potential of AI in reducing the time scientists spend on repetitive tasks, stating, "The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies."

The pilot demonstrated crucial time savings, with tasks that would usually take days, now completed in minutes. Jinzhong Liu, Deputy Director at the Office of Drug Evaluation Sciences, stated, "This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days."

Also, Chief AI Officer Jeremy Walsh and Sridhar Mantha, who were newly appointed, will coordinate the FDA's AI integration. The rollout will improve usability, expand document integration, and tailor outputs to specific center needs while maintaining strict information security and compliance with FDA policies.

The FDA says that they “…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.”

This pilot was announced on  the  following  website  on 8 May: https://www.fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai