FDA Unveils Agency-Wide AI Tool Elsa to Accelerate Scientific Review and Operational Efficiency

The U.S. Food and Drug Administration has launched Elsa, a generative AI tool designed to optimize performance across the agency. Built to improve internal workflows from scientific review to field inspections, Elsa represents the FDA’s latest effort to integrate advanced technologies for public service delivery.

Elsa, developed within a high-security GovCloud environment, provides FDA staff with secure access to internal documents. Importantly, the model does not train on data submitted by regulated industries, maintaining the confidentiality of sensitive research.

“Following a very successful pilot program with FDA’s scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.”

Accelerating Scientific Review and Inspections

Elsa is already being used to streamline multiple agency functions. The AI tool is enhancing clinical protocol reviews, reducing the time required for scientific evaluations, and helping identify high-priority inspection targets.

Designed to read, write, and summarize complex information, Elsa supports regulatory work by generating code, comparing drug labels, and summarizing adverse event reports. These capabilities allow employees to make faster, more informed decisions.

“Today marks the dawn of the AI era at the FDA with the release of Elsa,” said FDA Chief AI Officer Jeremy Walsh. “AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee.”

Built for Security and Scalability

Security and internal control remain central to Elsa’s deployment. Operating within a protected cloud architecture, the tool ensures data integrity and agency compliance. No externally submitted or proprietary industry data is used in its training process.

As adoption expands, the FDA plans to scale Elsa’s capabilities based on employee needs. Future developments may include broader AI integrations in data processing, regulatory research, and generative content creation.

AI-Driven Transformation at the FDA

Elsa is the first step in the FDA’s broader artificial intelligence roadmap. By launching the tool ahead of schedule, the agency demonstrates both technological leadership and operational foresight.

The initiative reflects a cross-center collaboration, highlighting how strategic innovation can modernize government operations. As Elsa evolves, the FDA is positioning itself as a model for responsible AI implementation in public health governance.