The FDA has introduced Elsa, an internal AI tool to review safety data, identify labeling issues, and prioritize inspections, ...

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

The FDA is using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations and identify high-priority inspection targets. The Food and Drug Administration ...

Makary made no mention of FDA resourcing in his introduction to Elsa, simply trumpeting its capabilities by saying: "One scientific reviewer told me what took 2–3 days now takes 6 minutes." ...

One new tool, named Elsa, is similar to ChatGPT and may help the FDA review safety data, summarize reports and flag which drug or food facilities need inspection, The New York Times reported.

Elsa’s launch also came on the heels of Trump’s 2026 budget proposal (PDF), which recommends cutting the FDA’s budget by 4%, including the cutting of 1,940 staff salaries.

On June 2, the FDA dropped the other shoe, saying it had launched a generative AI tool called “Elsa” to help scientific reviewers and investigators work more efficiently.

FDA Will Use AI to Approve Drugs and Devices Faster The agency launched a large-language model, dubbed Elsa, just last week to streamline operations.

Elsa may help process up to 500,000 pages of submitted data, the agency said. But there are limits. Some FDA staff said Elsa often gave wrong answers, what experts call “hallucinations”, and ...