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

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

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 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.

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.

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 ...

The FDA’s AI program needs to have guardrails in place to ensure it’s working properly. No matter what AI is used for at the FDA, processes must be in place to ensure fairness and accuracy ...

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 ...