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's new genAI-assisted scientific review technology, named Elsa, was officially adopted by the agency on 2 June.

Unveiled on June 2, 2025, Elsa, which functions within a highly secure GovCloud environment, marks the beginning of the agency’s broader integration of AI into its processes. According to FDA ...

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’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.

FDA Commissioner Dr. Marty Makary speaks during a news conference at HHS on April 22, 2025 in Washington, DC. ·Pharma Voice·Andrew Harnik via Getty Images Amy Baxter Mon, Jun 30, 2025, 4:00 AM4 ...

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.

More information: Martin A. Makary et al, Priorities for a New FDA, JAMA (2025). DOI: 10.1001/jama.2025.10116 The U.S. Food and Drug Administration has more on its development and approval process.