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.
17 Articles
17 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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