FDA announces Elsa, an AI tool

June 9, 2025

The U.S. Food and Drug Administration (FDA) released a new generative Artificial Intelligence (AI) tool to aid their employees.

The tool, Elsa, “offers a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency. The models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff.”

Furthermore, the FDA “is already using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets.” Elsa can “summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications.”

The agency will “integrate more AI in different processes,” according to the announcement.

FDA has the announcement