FDA Deploys Agentic AI Capabilities for Agency Staff

Published on: December 2, 2025

The agency is expanding its use of artificial intelligence (AI) with the deployment of agentic AI for staff to create more complex AI workflows and harness AI models.

FDA announced on Dec. 1, 2025 that it will be providing agency staff with agentic artificial intelligence (AI) capabilities that will enable the creation of complex AI workflows, harness AI models, and assist with multi-step tasks. The deployment is part of FDA’s initiative to embed AI more deeply into workflows to achieve operational efficiency.

“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 stated in a press release (1).

Agentic AI are advanced AI systems used for planning, reasoning, and executing multi-step actions with built-in guidelines for reliable outcomes. A two-month Agentic AI Challenge will be launched by the agency to encourage staff members to build Agentic AI solutions that will be demonstrated at the FDA Scientific Computing Day in January 2026.

How will Agentic AI be used by FDA?

While use of the Agentic AI will be optional and voluntary for FDA staff, the agency says it will help staff with meeting management, pre-market reviews, validation reviews, post-market surveillance, inspections, compliance, and administrative functions. Models will be built within high-security GovCloud environments and will not train on input data, or any submitted regulatory industry data, ensuring sensitive research is safe.

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

In what other ways is FDA using AI?

In June 2025, FDA launched Elsa, a generative AI tool for staff use. Elsa was also built within a high-security GovCloud environment for staff to securely access internal agency documents. Elsa is being used by FDA to accelerate clinical protocol reviews, scientific evaluations, and identify inspection targets.

Elsa is a large language model (LLM) designed to assist with reading, writing, and summarizing to support safety profile assessments, label comparisons, and help develop databases for nonclinical applications.

“Following a very successful pilot program with FDA’s scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30,” Makary said in a press release at the time (2). “Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.”

What is AI’s impact on the pharma industry?

AI has been a hot topic at many recent industry conferences and events. It is becoming more widely used in the industry in a variety of areas. There were a variety of discussions on AI’s use in bioanalysis at the AAPS PharmSci 360 conference, which was held in November 2025. Pharmaceutical Technology® spoke with Long Yuan, PhD, director of the Department of Drug Metabolism and Pharmacokinetics at Biogen about how AI, machine learning, and LLM are being utilized for bioanalysis.

“There is significantly increased interest and a great potential for AI to make a significant impact on various aspects of bioanalysis, including improving the quality, efficiency, compliance, and also reducing human errors,” Dr. Yuan said (3). The full interview can be watched on PharmTech.com.

References

FDA. FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment. Press Release. Dec. 1, 2025. https://www.fda.gov/news-events/press-announcements/fda-expands-artificial-intelligence-capabilities-agentic-ai-deployment
FDA. FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People. Press Release. June 2, 2025. https://www.fda.gov/news-events/press-announcements/fda-launches-agency-wide-ai-tool-optimize-performance-american-people
Haigney, S. How AI, Machine Learning, and Large Language Models Enhance Bioanalysis. PharmTech.com. Nov. 7, 2025. https://www.pharmtech.com/view/how-ai-machine-learning-and-large-language-models-enhance-bioanalysis