The U.S. Food and Drug Administration (FDA) has announced the rollout of agentic artificial intelligence (AI) tools to all of its employees, marking a significant expansion of the agency’s AI capabilities. Agentic AI refers to advanced systems capable of orchestrating complex, multi-step workflows by planning, reasoning, and executing tasks while adhering to built-in guidelines and human oversight to ensure reliable results. Use of these new AI tools at the FDA is voluntary for staff.
FDA Commissioner Marty Makary highlighted the potential benefits of these tools, emphasizing that this is a pivotal moment to modernize the agency's operations to accelerate the development and approval of new treatments. Earlier this year, over 70% of FDA staff began using Elsa, a language model-based AI assistant, with continuous improvements integrating it into various workflows.
The newly deployed agentic AI will enable staff to handle more complex operations such as managing meetings, conducting pre-market and post-market reviews, validating regulatory submissions, supporting inspections and compliance, and performing administrative functions more efficiently. To encourage innovation, the FDA will host a two-month Agentic AI Challenge, where teams can develop solutions that will be showcased in January 2026 at the FDA Scientific Computing Day.
Jeremy Walsh, FDA’s Chief AI Officer, noted that the agency’s reviewers have been creative in employing AI tools, and this new capability will further streamline workflows and enhance the FDA's ability to ensure that regulated products meet safety and efficacy standards.
Importantly, the agentic AI models operate within a secure government cloud environment, ensuring that sensitive research and data remain protected. These models do not train on input data or data from regulated entities, safeguarding proprietary and confidential information. This deployment represents a vital step forward in embedding AI throughout FDA operations to achieve unprecedented operational efficiency and regulatory excellence.
Learn more: FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment
