The U.S. Food and Drug Administration (FDA) has announced the deployment of agentic artificial intelligence (AI) capabilities for all staffers, including reviewers, scientists, and investigators. The agentic AI rollout is intended to improve operational efficiency by enabling the creation of more complex AI workflows, harnessing various AI models, to assist with multi-step tasks.

Agentic AI refers to advanced AI 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. FDA says Agentic AI is optional for FDA staff and may be used voluntarily.  

In May 2025, the agency deployed a large language model (LLM)-based tool, Elsa, which is now voluntarily used by more than 70 percent of staff, according to internal agency data. Since the initial deployment, FDA program teams have driven frequent modifications to better integrate Elsa into workflows.  

The December 2025 agentic AI deployment will enable FDA staff to further advance the use of AI to assist with more complex tasks, such as meeting management, pre-market reviews, review validation, post-market surveillance, inspections and compliance, and administrative functions.

As part of its 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 January 2026 FDA Scientific Computing Day.

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.