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FDA Embraces AI Future with Successful Pilot and Bold Expansion Plan

June 14, 2025

With the AI being integrated in almost everything nowadays, FDA has decided to dive in and also integrate AI in their practice.

AI has proven to be an exceptional choice, significantly enhancing efficiency by streamlining tasks and minimizing unnecessary delays. Its ability to accelerate processes such as the review of new therapies has positioned it as a valuable tool in daily operations. As Jinzhong (Jin) Liu, Deputy Director of the Office of Drug Evaluation Sciences, noted, “This is a game-changing technology that has allowed me to complete scientific review tasks in minutes that previously took three days.”

With AI showing promising results in reviews processes pilot, FDA Commissioner Martin A. Makary has decided to fully integrate Ai in all operating centers using secure unified system by the end of June.

Future improvements will aim to enhance usability, expand integration with various document types, and customize outputs to meet the specific needs of different FDA centers all while ensuring strong information security and adherence to FDA policies. The agency will continue to monitor performance, collect user feedback, and refine the system to better support FDA staff and further its public health mission.

Learn more:  FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline | FDA

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