FDA Starts Implementing AI Rollout Across All Centers
After a successful AI-assisted scientific pilot review, the agency has decided to implement the use of AI across all centers in an accelerated timescale.
After the completion of the agency’s first artificial intelligence (AI) assisted scientific review, FDA Commissioner, Martin A. Makary, M.D., M.P.H., has revealed plans to implement the use of AI throughout the agency within an expedited timeframe. According to an FDA announcement, the completion for rollout of AI internally across all FDA centers is expected to be June 30, 2025 (1).
“I was blown away by the success of our first AI-assisted scientific review pilot,” said Makary, in the FDA announcement (1). “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.”
All FDA centers have been directed to start the deployment of AI capabilities immediately, reflecting the urgency of this effort. By June 30, 2025, all FDA centers should be operating on a common, secure generative AI system that has been integrated with internal data platforms; however, work will continue beyond this date to expand use cases, improve functionality, and adapt to evolving needs as they arise.
“There have been years of talk about AI capabilities in frameworks, conferences, and panels but we cannot afford to keep talking. It is time to take action. The opportunity to reduce tasks that once took days to just minutes is too important to delay,” added Makary, in the FDA announcement (1).
Additionally, as reported in WIRED (2), the agency has been in talks with OpenAI to discuss the use of AI to speed up the drug approval process. While Makary hasn’t alluded to using OpenAI in particular, sources have confirmed that multiple meetings between OpenAI, FDA, and two associates of Elon Musk’s Department of Government Efficiency have taken place in recent weeks (2).
The agency issued its first draft guidance about using AI in support of regulatory submissions in January 2025 (3). However, there has also been an exponential increase in the use of AI in drug development and regulatory submissions since 2016, meaning that the agency has already had substantial experience in reviewing submissions with AI components.
“The FDA is committed to supporting innovative approaches for the development of medical products by providing an agile, risk-based framework that promotes innovation and ensures the agency’s robust scientific and regulatory standards are met,” said ex-FDA Commissioner Robert M. Califf, M.D., in an FDA announcement about the draft guidance (3). “With the appropriate safeguards in place, artificial intelligence has transformative potential to advance clinical research and accelerate medical product development to improve patient care.”
References
FDA. FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline. Press Release, May 8, 2025.
Schiffer, Z.; Mullin, E.; Knight, W. OpenAI and the FDA are holding Talks About Using AI in Drug Evaluation. WIRED, May 7, 2025.
FDA. FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions. Press Release, Jan. 6, 2025.