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.
19 Articles
19 Articles
FDA claims victory with "Elsa" AI tool launch, but insiders call it half-baked
The Food and Drug Administration has officially launched "Elsa," a generative artificial intelligence platform designed to help staff across the agency work more efficiently. However, internal critics argue the rollout moved too quickly and say the tool, in its current state, is underwhelming.Read Entire Article
Scientists argue for more FDA oversight of health care AI tools
An agile, transparent, and ethics-driven oversight system is needed for the U.S. Food and Drug Administration (FDA) to balance innovation with patient safety when it comes to artificial intelligence-driven medical technologies. That is the takeaway from a new report issued to the FDA, published this week in the open-access journal PLOS Digital Health by Leo Celi of the Massachusetts Institute of Technology and colleagues.


FDA rushed out agency-wide AI tool—it’s not going well
An agency-wide LLM called Elsa was released weeks ahead of schedule.
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