News Brief: FDA Expands AI with Agentic Deployment

The U.S. Food and Drug Administration (FDA) announced on December 1, 2025 that it has deployed “agentic” artificial-intelligence (AI) capabilities for all its employees. Agentic AI refers to advanced systems engineered to plan, reason, and carry out multi-step tasks. These tools are designed to assist the agency’s reviewers, scientists, and investigators by enabling more complex workflows — for example meeting management, pre-market reviews, review validation, post-market surveillance, inspections, compliance and general administrative work.

The FDA emphasizes that the use of agentic AI is entirely optional; staff may adopt it voluntarily. According to the agency, the models are implemented within a secure GovCloud environment and do not train on staff inputs or on any data submitted by regulated industry — a safeguard meant to protect sensitive research and regulatory information.

This rollout builds on a prior initiative: in May 2025 the FDA introduced a generative-AI tool (named “Elsa”) and internal data suggest more than 70% of staff now use it voluntarily. With the new agentic-AI deployment, the agency intends to deepen the role of AI in its operations, supporting more complex tasks than were previously handled by simpler generative models.

As part of the rollout, the FDA is launching a two-month “Agentic AI Challenge,” encouraging staff to create and test new workflows leveraging these tools. The results will be showcased at the FDA Scientific Computing Day in January 2026.