The US Food and Drug Administration (FDA) has announced plans to implement generative artificial intelligence (AI) tools across all its centers by June 30, 2025. The move follows the agency’s first successful pilot using AI to support scientific review tasks.

FDA Commissioner Dr. Martin Makary called the pilot a “game-changer” in streamlining regulatory workflows. “We need to value our scientists’ time and reduce non-productive busywork,” he said, noting that the AI tools significantly accelerated review timelines for new therapies.

The pilot demonstrated that generative AI can complete routine scientific review tasks in minutes—a process that previously took several days. Jinzhong Liu, Deputy Director at the Office of Drug Evaluation Sciences, confirmed the time savings. “This technology enabled me to perform tasks in minutes that used to take three days,” he said.

The FDA’s internal AI platform, built with a focus on security and data integration, will be adapted to each center’s needs but will operate on a unified system. The tools aim to reduce time spent on administrative burdens such as summarizing documents, checking data consistency, and extracting regulatory insights from previous approvals.

To meet the agency’s June 30th deadline, centers have been instructed to begin immediate deployment.

Ongoing development will continue beyond this date to expand use cases and improve usability while ensuring compliance with regulatory frameworks and data protection policies.

The rollout is being coordinated by Jeremy Walsh, the FDA’s first chief AI officer, and Sridhar Mantha, formerly of the Office of Business Informatics.

Walsh brings experience in deploying large-scale digital platforms across federal agencies, including those in health and intelligence sectors.

While many regulatory bodies have discussed the promise of AI, few have committed to full-scale integration on this timeline. “We’ve seen years of talk about AI frameworks and conferences,” said Makary.

“Now is the time to act.”

Experts outside the agency say the FDA’s move reflects growing pressure to modernize regulatory review. “Agencies are under enormous pressure to keep pace with scientific innovation,” said Dr. Sheila Patel, a digital health policy advisor.

“AI tools if well governed could improve speed without compromising safety or rigor.”