The Food and Drug Administration said it is rolling out “agentic AI” tools across the agency, expanding beyond a large-language-model assistant adopted by most staff earlier this year. The optional system, designed to plan and execute multi-step tasks under human oversight, will support meeting management, pre-market reviews, validation, post-market surveillance, inspections and administrative work, according to the agency. Commissioner Marty Makary said the move aims to speed reviews and “accelerate more cures and meaningful treatments.” The tools operate in a high-security GovCloud environment and won’t train on staff inputs or industry submissions, the FDA said. The agency also launched a two-month internal challenge to develop use cases ahead of a January 2026 demonstration. The deployment underscores a broader federal push to adopt AI within established governance and risk frameworks while safeguarding sensitive health and regulatory data.
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