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

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

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.

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

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

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

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 In January 2025, the agency issued a draft guidance on considerations for the use of AI to support ...

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

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

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, the FDA dropped the other shoe, saying it had launched a generative AI tool called “Elsa” to help scientific reviewers and investigators work more efficiently.

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