FDA Deploys Agentic AI to Accelerate Drug Approvals and Enhance Public Safety
The U.S. Food and Drug Administration is equipping its workforce with advanced agentic AI capabilities, marking a significant step toward modernizing operations and accelerating the delivery of critical treatments. The agency announced the voluntary deployment of the technology to all employees on December 1, 2025.
The move builds upon the FDA’s earlier adoption of large language model (LLM) technology, with over 70% of staff already utilizing the LLM-based tool, Elsa, since its release in May. This latest expansion introduces agentic AI, a more sophisticated form of artificial intelligence designed to tackle complex, multi-step tasks through planning, reasoning, and execution – all while incorporating human oversight.
“We are diligently expanding our use of AI to put the best possible tools in the hands of our reviewers, scientists and investigators,” stated 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.”
Agentic AI will assist FDA staff across a broad spectrum of functions, including streamlining meeting management, accelerating pre-market reviews, validating reviews, enhancing post-market surveillance, improving inspections and compliance, and optimizing administrative processes. To foster innovation and practical application, the agency is launching a two-month Agentic AI Challenge, culminating in a showcase 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.
A key priority in the deployment is data security. The agentic AI models operate within a high-security GovCloud environment and are specifically designed not to train on input data or any information submitted by regulated industries, safeguarding sensitive research and proprietary data. This commitment to security underscores the FDA’s responsible approach to AI integration.
The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of a wide range of products, including human and veterinary drugs, vaccines, medical devices, food, cosmetics, and tobacco. This deployment of agentic AI represents a major step in the agency’s ongoing efforts to embed AI more deeply into its workflows and achieve unprecedented operational efficiency, ultimately benefiting public health.
