Martin Makary, in one of his first actions as FDA Commissioner, has directed all FDA Centers to begin deploying an AI-assisted review system immediately, with the goal of reducing the time it takes to conduct tasks during scientific reviews. FDA said it will push an “aggressive timeline” to roll out AI tools across its centers with the goal of “full integration” by 30 June.
However, FDA provided scant details about the pilot and did not specify what types of products or tasks were involved, nor did it elaborate on the types of tasks AI could assist with once it is fully integrated this June. In recent years, FDA has investigated the use of AI for internal processes and in August 2024 formed an internal AI council within the Center for Drug Evaluation and Research (CDER) to oversee its AI-related activities, and former FDA Commissioner Robert Califf discussed exploring the use of AI technologies in its internal operations and regulatory processes earlier that year.
The Agency has also observed a significant increase in drug submissions that include AI components in recent years. “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,” said Makary.
Jinzhong (Jin) Liu, Deputy Director with the Office of Drug Evaluation Sciences in the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER), echoed these sentiments. “This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days.”
FDA announced that during the rollout, work will continue to expand uses, improve functionality and adapt to the evolving needs of each center. By 30 June, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.
Future improvements will aim to enhance usability, increase document integration, and customize outputs to meet the specific needs of each center, all while ensuring strict information security and compliance with FDA policies.
The Agency-wide rollout is being led by Jeremy Walsh, the FDA’s newly appointed Chief AI Officer and Sridhar Mantha. Before joining FDA, Walsh was the Chief Technologist at Booz Allen Hamilton for 14 years, while Mantha recently led the Office of Business Informatics in CDER. According to a recent article in Wired, Walsh is reportedly in talks with OpenAI employees to discuss AI and a project called cderCGT.
Commissioner Makary addressed the need to shorten the drug approval process by using AI at the American Hospital Association’s (AHA) annual membership meeting in Washington, DC in middle MAY 2025. He stated that “we at the FDA now have to ask big questions that we’ve never asked before. Why does it take over 10 years for a new drug to come to market? Why are we not modernized with AI and other things?”
REFERENCE: Regulatory Focus (News and Peer Reviewed Content)/Regulatory News; 08 MAY 2025; Joanne S. Eglovitch