FDA sets aggressive timeline to integrate AI across all centers by June 2025

Investing.com -- In a groundbreaking move, FDA Commissioner Martin A. Makary, M.D., M.P.H., announced today a bold plan to expand the use of artificial intelligence (AI) across all FDA centers by June 30, 2025. This follows the successful completion of a new generative AI pilot for scientific reviewers.

Dr. Makary expressed his satisfaction with the results of the AI-assisted scientific review pilot, emphasizing the potential for these tools to streamline the review process for new therapies. The generative AI technology allows FDA scientists and experts to spend less time on repetitive tasks, thus improving the efficiency of the review process.

Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER), praised the technology, noting that tasks that previously took three days can now be completed in minutes.

Dr. Makary has instructed all FDA centers to begin immediate deployment of the AI tools, with the objective of achieving full integration by the end of June. The plan includes ongoing work to expand use cases, enhance functionality, and adapt to the changing needs of each center after June 30. By this date, all centers are expected to be operating on a secure, common generative AI system integrated with FDA’s internal data platforms.

Looking forward, the FDA plans to broaden the application of generative AI capabilities across all centers using a secure, unified platform. Future improvements will focus on enhancing usability, broadening document integration, and customizing outputs to the specific needs of each center, while maintaining strict information security and compliance with FDA policy.

The agency-wide implementation is being overseen by Jeremy Walsh, the FDA’s newly appointed Chief AI Officer, and Sridhar Mantha. Walsh has extensive experience leading large-scale technology deployments across federal health and intelligence agencies, and Mantha recently headed the Office of Business Informatics in CDER.

The FDA will continue to evaluate performance, collect user feedback, and refine features in order to support the evolving needs of FDA staff and further its public health mission. More information and updates on the initiative will be made public in June.

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