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3w ago

FDA launches AI assistant Elsa early as staff flag readiness issues

Some employees caution that Elsa may have been rushed before reaching full functionality

FDA headquarters at White Oak Campus in Silver Spring, Maryland, USA.
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly
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artificial intelligence AI Breaking Push white house FDA food and drug administration elsa

Overview

  • Elsa was deployed agency-wide on June 3, beating its June 30 deadline and coming in under budget
  • The tool is designed to help FDA reviewers summarize adverse event reports, compare drug labels, generate code for nonclinical databases and identify high-risk inspection targets
  • Staff feedback warns the accelerated rollout left Elsa without adequate guardrails and that some summaries and outputs have been incomplete or inaccurate
  • FDA leaders plan to iterate on Elsa’s features using real-world user feedback and to expand its applications across different centers
  • A separate medical-device AI, CDRH-GPT, remains in beta testing and is handicapped by bugs in document uploads and system integration