Overview

• The agency deployed ELSA organization-wide ahead of schedule and under budget following a pilot that amassed thousands of staff interactions since January.
• FDA Commissioner Marty Makary says tasks that once took two to three days now require just six minutes with ELSA’s assistance.
• Built by Deloitte on Anthropic’s Claude LLM, ELSA operates within a secure GovCloud environment and does not train on industry-submitted data.
• Staffers describe the tool as buggy and lacking policy guardrails, cautioning against its use for scientific reviews until functionality stabilizes.
• ELSA currently aids in summarizing adverse event data, comparing drug labels, generating basic database code and prioritizing inspection sites, with plans for iterative improvements based on user feedback.