Overview

• Elsa, the FDA’s first agency-wide generative AI tool, launched June 2 after a successful pilot with scientific reviewers.
• The system helps scientific reviewers and field investigators by speeding protocol assessments, adverse event summaries, label comparisons and identifying high-priority inspection targets.
• Elsa’s models do not train on regulated industry submissions, preserving confidentiality of proprietary research.
• Built in a secure GovCloud environment, the rollout completed under budget and ahead of the FDA’s June 30 target.
• FDA plans to broaden Elsa’s AI-driven functions in data processing, user interfaces and tailored outputs as adoption grows.