Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

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

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

FDA officials say the assistant is flawed, just as the Trump administration stresses AI adoption in healthcare.

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

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

The advent of artificial intelligence (AI) at the US Food and Drug Administration (FDA) is changing the complexion of the regulatory approval process for medical devices.

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

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

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug ...

"Elsa" is supposed to speed up the process of approving drugs and medical devices. But FDA employees say the AI is creating ...

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 ...