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

  • The FDA officially launched Elsa, a generative AI tool, on June 2, 2025, to assist staff across the agency in improving efficiency.
  • The rollout followed a successful pilot and an aggressive timeline set by Commissioner Marty Makary to scale Elsa agency-wide by June 30.
  • Despite claims Elsa accelerates clinical reviews and reduces busywork, internal users report bugs, inaccuracies, and basic usability issues with the tool.
  • Makary noted that the launch of Elsa was completed earlier than planned and within financial limits, attributing this success to the teamwork of internal specialists from various centers.
  • This mixed reception suggests Elsa’s future success depends on agency responsiveness to staff feedback and ongoing improvements amid a push to modernize FDA operations.
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The Epoch Times broke the news in New York, United States on Tuesday, June 3, 2025.
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