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 ...

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

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 ...

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

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

Following FDA’s first AI-assisted medical product review, the agency has committed to expanding the use of generative AI across all centers by June 30, 2025. Commissioner Makary emphasized the ...

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.

FDA said it intends to gather additional input for identifying types of information that FDA would recommend a manufacturer include in the labeling of AI/ML-based medical devices. 4.