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FDA Rushed Out Agency-Wide AI Tool—It’s Not Going Well

  • The FDA launched Elsa, a generative AI tool intended to assist employees agency-wide as of early June 2025.
  • This rollout accelerated because of a pilot program's success and pressure to modernize amid workforce cuts and regulatory scrutiny.
  • Despite claims of improved efficiency, users report Elsa performs basic tasks poorly and delivers inaccurate summaries during early testing.
  • FDA Commissioner Marty Makary praised the rollout as "ahead of schedule and under budget" but acknowledged the tool is not yet perfect.
  • Internal criticism and expert analysis suggest the FDA needs more transparent, adaptive oversight for AI to balance innovation with patient safety.
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The Epoch Times broke the news in New York, United States on Tuesday, June 3, 2025.
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