The FDA has launched its generative AI Elsa

Elsa is the name of the new generative artificial intelligence tool launched on 2 June 2025 by the U.S. Food and Drug Administration (FDA). The launch occurred just a few weeks after the completion of the pilot project, which aimed to validate the use of Elsa to support the work of FDA’s staff (e.g. scientific reviewers, investigators, etc). 

Built within a high-security GovCloud environment, Elsa provides secure access to internal documents, while ensuring that all information remains within the agency. The models are not trained on data submitted by the regulated industry, thus safeguarding the sensitive research and data handled by FDA staff.

Elsa is an AI tool powered by large language models designed to assist with reading, writing, and summarising. According to the FDA, Elsa will be used to accelerate the review of clinical protocols, shorten the time taken for scientific evaluations, and identify high-priority inspection targets. For example, Elsa can summarise adverse events to support safety profile assessments, perform faster label comparisons, and generate codes to help develop databases for nonclinical applications.