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 ...

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

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.

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

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

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

Y ou'd have to be a special kind of Luddite to think that artificial intelligence won't change health care. The word ...

The administration's commissioner says scientists are using the AI for its organizational ability. Astronomer HR chief ...

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

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 In January 2025, the agency issued a draft guidance on considerations for the use of AI to support ...