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

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

One of the concerns people have when they hear FDA is using AI in the drug approval process is that many people don't have a ...

The U.S. Food and Drug Administration (FDA) has introduced “Elsa,” a generative AI tool designed to enhance the efficiency of its regulatory operations.

Welcome to the inaugural issue of the Food Exec Brief — our new weekly roundup of key headlines for food manufacturing ...

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.

FDA’s Broader AI Goals. The launch of Elsa is part of a broader “AI-forward” strategy. In January 2025, the agency issued a draft guidance on considerations for the use of AI to support ...

It said Elsa is a large language model-powered AI tool built within a “high-security GovCloud environment.” The FDA said the tool will assist with reading, writing and summarizing information.

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 ...

The U.S. Food and Drug Administration said on Monday that it had launched a generative AI tool, Elsa, aimed at improving efficiency across its operations, including scientific reviews.