FDA offers staff ‘agentic AI’ to support premarket reviews, administrative tasks
December 2, 2025

(STAT News) – The Food and Drug Administration on Monday announced plans to offer its employees a broader set of artificial intelligence tools to use in premarket reviews and for other purposes amid persistent concerns that the technology can behave unpredictably.
The agency touts in a release that staff will now be able to use “agentic AI capabilities” to assist with “meeting management, pre-market reviews, review validation, post-market surveillance, inspections and compliance and administrative functions.” Agentic AI broadly refers to systems that can complete multistep tasks autonomously. The announcement says that the agency is employing “guidelines — including human oversight — to ensure reliable outcomes.” (Read More)