Food and Drug Administration Commissioner Martin Makary has directed all FDA centers to kick off artificial intelligence deployment and achieve full integration by the end of June.
The FDA said Thursday the announcement comes after the agency completed a generative AI pilot for scientific reviewers.
Makary commended the first AI-assisted scientific review pilot.
“The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” he said.
By the end of June, all FDA centers are expected to operate on a common generative AI system integrated with the agency’s internal data platforms. FDA also expects to improve AI functionality and expand use cases.
“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,” Makary stated.
Agencywide AI Deployment & Future Plans
Jeremy Walsh, the FDA’s newly appointed chief AI officer, and Sridhar Mantha, director of the FDA Center for Drug Evaluation and Research’s Office of Strategic Programs, are coordinating the agencywide rollout of AI capabilities.
The agency intends to broaden generative AI capabilities using a secure, unified platform.
FDA expects future improvements to focus on expanding document integration, enhancing usability and tailoring outputs to center-specific requirements while complying with the agency’s policy and maintaining strict data security.
The agency will continue to collect user feedback, evaluate performance and improve features to meet its staff’s evolving needs and advance its public health mission.
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