The U.S. Food and Drug Administration (FDA) has announced that it is rolling out an agentic AI tool to all employees which will allow them to build more complex AI-driven workflows that combine multiple models to support multi-step tasks. In a press release, FDA notes that the use of the tool is voluntary for FDA employees.
FDA expects the tool will help staff to expand their use of AI for more complex activities, including meeting management, pre-market reviews, review validation, post-market surveillance, inspections and compliance, and various administrative tasks.

“We are diligently expanding our use of AI to put the best possible tools in the hands of our reviewers, scientists and investigators. 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,” FDA Commissioner Marty Makary, M.D., M.P.H, said.

To support this deployment, the agency is also launching a two-month Agentic AI Challenge, inviting staff to develop agentic AI solutions and showcase them at FDA’s 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,” Chief AI Officer Jeremy Walsh added.