FDA Announces ‘Aggressive’ AI Implementation Timeline

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The pharma industry has openly embraced AI in recent years. The technology has been implemented across various aspects of the industry, starting at the drug development phase and going all the way through to the marketing phase. Now, according to a press release, AI is going to be involved in FDA’s review and approval process.

FDA commissioner Martin A. Markary, MD, MPH, announced that the agency plans to implement an “aggressive” timeline for the implementation of AI across all FDA centers.¹ This decision was made based on the results of a generative AI pilot for scientific reviewers.

FDA describes the technology as providing FDA scientists with the tools to avoid tedious and repetitive tasks. This will allow them to focus on more important aspects of the review process.

In a press release, Markary said, “I was blown away by the success of our first AI-assisted scientific review pilot. 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.”

Markary continued, “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.”

According to the agency, FDA plans to expand the use of generative AI through the use of a unified, secure platform. The agency recently appointed Jeremy Walsh as its first chief AI officer. Walsh, along with CDER’s director of strategic programs Sridhar Mantha, will oversee the implantation of the technology across the agency.

In the same press release, Jinzhong (Jin) Liu, deputy director of the office of drug evaluation sciences at the Office of New Drugs in FDA’s Center for Drug Evaluation and Research, said, “This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days.”

This is one of the first major decisions made by FDA commissioner Markary, who took office in late March of this year.² In a press release dated April 1, he said, ““I am honored and humbled to assume this role at the FDA under the leadership of President Trump and Secretary Kennedy. I look forward to working with this Administration and the FDA workforce to advance our shared goals in meeting the agency’s public health mission. As Commissioner, I hope to ensure that the FDA holds to the gold standard of trusted science, transparency, and common sense so that we can Make America Healthy Again.”

In the same press release, HHS secretary Robert F. Kennedy, Jr., said, “I am pleased to welcome Dr. Makary to the U.S. Department of Health and Human Services and the Food and Drug Administration. He is a national leader in medicine with impeccable credentials. His extensive research, clinical experience, and national leadership make him uniquely qualified to lead the FDA as we work together to Make America Healthy Again.”

Sources

1. FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline. FDA. May 8, 2025. https://www.fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai?utm_medium=email&utm_source=govdelivery
2. Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner. FDA. April 1, 2025. Accessed May 8, 2025. https://www.fda.gov/news-events/press-announcements/martin-makary-md-mph-sworn-fda-commissioner