FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment

The U.S. Food and Drug Administration has announced a significant expansion of its internal artificial intelligence capabilities through the deployment of agentic AI tools across the agency. The new system is designed to help FDA staff manage complex, multi-step tasks more efficiently while maintaining strict oversight and data protections.

Agentic AI refers to advanced systems that can plan, reason, and execute actions toward specific goals. The FDA noted that the deployment is fully optional for staff, but is expected to enhance operations for reviewers, scientists, investigators, and administrative teams.

Background and Context

Earlier this year, the FDA introduced Elsa, an LLM-based tool now used voluntarily by more than 70% of agency personnel. Based on internal feedback, the FDA has continued refining its AI toolset to better support evolving workflows and data demands. The move toward agentic AI represents the next step in this modernization effort.

Key Features and Expected Impact

According to the FDA announcement, the new agentic AI capabilities will support multi-step tasks across several areas, including:

• Meeting management and decision workflows

• Pre-market reviews and review validation

• Post-market surveillance and signal evaluation

• Inspection and compliance activities

• Administrative and operational functions

To encourage innovation, the agency is launching a two-month Agentic AI Challenge where FDA staff will develop and demonstrate AI-driven workflow solutions. These will be showcased at the upcoming Scientific Computing Day in January 2026.

Data Security and Model Safeguards

The system is deployed within a high-security GovCloud environment, and FDA emphasized that models do not train on input data or on any information submitted by regulated industry. This safeguard is intended to protect sensitive regulatory submissions and prevent inadvertent data reuse.

Statements from FDA Leadership

FDA Commissioner Marty Makary, M.D., M.P.H., highlighted the modernization benefits:

“We are diligently expanding our use of AI to put the best possible tools in the hands of our reviewers, scientists and investigators… 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.”

Chief AI Officer Jeremy Walsh added:

“Agentic AI will give [reviewers] a powerful tool to streamline their work and help them ensure the safety and efficacy of regulated products.”

EAS Perspective

FDA’s rapid expansion of internal AI use signals a continued push toward modernization of review and oversight functions. As the agency builds more AI-supported workflows, regulated industry can expect increased consistency, faster data processing, and more digital engagement across the product lifecycle.

EAS will continue monitoring FDA’s AI initiatives and share updates as they evolve.