Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...

Hallucinations are a known problem with generative AI models—and Elsa is no different, according to Jeremy Walsh, the head of ...

The federal agency introduced Elsa last month, boasting about the AI tool's ability to increase efficiency at the FDA.

The FDA's generative AI, Elsa, has a massive hallucination problem, according to the agency's employees themselves.

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.

Meanwhile, FDA Commissioner Marty Makary highlighted the speed with which the tool was rolled out. "I set an aggressive timeline to scale AI agency-wide by June 30," Makary said.

The FDA already has ways to speed up the approval process for promising drugs, such as fast track and breakthrough therapy designations. AI could add another layer of efficiency, but it must be ...

And according to Robert Califf, who served as FDA commissioner between 2016 and 2017, the agency review teams have already been experimenting with AI for several years.

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool ...

The U.S. Food and Drug Administration (FDA) has approved the first artificial intelligence (AI) tool to predict breast cancer risk. The authorization was confirmed by digital health tech company ...