FDA Agentic AI Deployment

Date

December 2, 2025

Category

US Regulations

Description

On 1 December 2025 FDA announced the deployment of agentic AI capabilities for all agency employees, see FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment | FDA.

Agentic AI refers to advanced artificial intelligence systems designed to achieve specific goals by planning, reasoning, and executing multi-step actions. These systems incorporate built-in guidelines — including human oversight —to ensure reliable outcomes. The tool is entirely optional for FDA staff and is used voluntarily. 

“We are diligently expanding our use of AI to put the best possible tools in the hands of our reviewers, scientists and investigators,” said FDA Commissioner Marty Makary.  “There has never been a better moment in agency history to modernize with tools that can radically improve our ability to accelerate more cures and meaningful treatments.”

As part of the agentic AI deployment, the agency is launching a two-month Agentic AI Challenge for staff to build Agentic AI solutions and demonstrate them at the FDA Scientific Computing Day in January 2026.

“FDA's talented reviewers have been creative and proactive in deploying AI capabilities — agentic AI will give them a powerful tool to streamline their work and help them ensure the safety and efficacy of regulated products,” said Chief AI Officer Jeremy Walsh. 

Built within a high-security GovCloud environment, the models do not train on input data nor any data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff. The deployment is another major step in the agency’s multifaceted plan to embed AI more deeply into workflows and achieve unprecedented operational efficiency.