The U.S. Food and Drug Administration (FDA) has officially launched “Elsa,” a generative AI tool designed to enhance the efficiency and performance of the agency’s workforce.
The tool, introduced on June 2, 2025, supports a wide range of staff—from scientific reviewers to field investigators—by expediting routine tasks and enabling faster, more accurate decision-making. Elsa is powered by large language models and operates within a secure GovCloud environment to ensure sensitive information remains internal and protected.
Chief AI Officer Jeremy Walsh said this marks the dawn of the AI era at the FDA. “AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee.”
FDA Commissioner Dr. Marty Makary praised the early rollout of Elsa, which was delivered ahead of its June 30 target and under budget. “Following a very successful pilot with FDA’s scientific reviewers, I set an aggressive timeline to scale AI agency-wide,” Makary said.
Elsa is already being used to accelerate clinical protocol reviews, assist with safety assessments by summarizing adverse event reports, perform faster label comparisons, and generate database code for nonclinical applications. The tool helps FDA staff read, write, and synthesize information quickly—cutting down on the time required for complex evaluations.
Importantly, the AI does not train on any data submitted by regulated industries, preserving the confidentiality and integrity of sensitive scientific and regulatory information.
The agency emphasized that Elsa’s launch is only the beginning of its AI journey. Plans are underway to expand AI integration into other FDA processes, such as data processing and advanced generative capabilities. As Elsa evolves, the agency will adapt its features to meet growing operational needs.
With Elsa’s debut, the FDA joins a growing list of federal agencies adopting AI to enhance productivity and service delivery, signaling a broader government shift toward secure, responsible AI innovation.
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