FDA Launches Widely-Anticipated AI Tool To Aid Scientific Reviewers and Investigators
June 3rd, 2025 // 1:08 pm @ jmpickett
It’s been a long time coming. Yesterday, FDA launched Elsa, an AI tool promised to help FDA employees work with greater efficiency. FDA says the tool will modernize various FDA functions and leverage AI capabilities to improve the drug and medical device improvement process.
Elsa was built in a high-security cloud environment, offering a secure platform for FDA workers to review internal documents, while ensuring that everything stays inside FDA walls. The AI models don’t learn from data submitted by FDAers, which safeguards sensitive data and research that FDA handles.
FDA reports that it is using Elsa this week to speed up clinical review protocols, shorten the period needed for various scientific evaluations, and pinpoint the most critical inspection targets.
Elsa is a language model-driven AI module that is supposed to help FDA employees with writing, reading, and summarizing. The model can summarize ADRs to support efforts for safety assessments, do faster label comparisons, and produce code to develop new databases for various nonclinical applications.
FDA launched Elsa ahead of schedule. We are keeping our eyes open for more news about Elsa. One key point we will investigate is how Elsa will be used to select the most critical sites for cGMP inspections.
