FDA announced it has deployed agentic AI capabilities to all its employees, which it says will enable complex AI workflows and build on the agency’s effort to integrate AI into everyday tasks.

Despite the agency-wide push for AI integration into employees’ daily tasks, FDA is not requiring its employees to use the too. Instead, it is labeling the tool as “entirely optional” for employee use, with expected use of the tool to be voluntary.¹

The agentic AI tool was created in a high-security GovCloud environment and was designed to not train on input data and or any data submitted by regulated industry to safeguard sensitive research and data handled by FDA staff.¹

“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, M.D., M.P.H. “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.”

What benefits will the agentic AI deployment give to FDA employees?

Agentic AI is comprised of multiple advanced artificial intelligence systems designed to achieve specific milestones through planning, reasoning, and execution of multi-step actions.¹ The artificial intelligence systems employ built-in guidelines along with human oversight which FDA says will ensure reliable outcomes.

The agency expects the deployment of agentic AI to streamline tasks for employees, specifically assisting with complex tasks such as:

• Pre-market reviews
• Meeting management
• Review validations
• Post-market surveillance
• Inspections and compliance
• Administrative functions

Along with the deployment and integration the new agentic AI tool, FDA is also launching an agentic AI challenge for its employees, asking staff to build agentic AI solutions over a two-month period and present them at FDA Scientific Computing Day in January 2026.¹

FDA continues its AI integration

FDA’s recent AI tool deployment builds on the agency’s previous AI deployment back in May this year, which saw the agency launch Elsa, a generative AI tool designed to improve employee workflow.²

Elsa is a large language model–powered AI tool created to assist employees with summarizing adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications.²

The agency considers Elsa as the “initial step” in its AI journey, saying that “as the tool matures, the agency has plans to integrate more AI in different processes.”²

Less than a year since its initial deployment, Elsa is reportedly used on a voluntary basis by upwards of 70% of the agency’s staff, according to internal agency data, and program teams have continued to drive frequent modifications aiming to better integrate Elsa into their workflows.

“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.

Sources

1. FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment U.S Food and Drug Administration December 1, 2025 https://www.fda.gov/news-events/press-announcements/fda-expands-artificial-intelligence-capabilities-agentic-ai-deployment
2. FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People U.S Food and Drug Administration June 2, 2025 https://www.fda.gov/news-events/press-announcements/fda-launches-agency-wide-ai-tool-optimize-performance-american-people