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

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

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

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

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 In January 2025, the agency issued a draft guidance on considerations for the use of AI to support ...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

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

AI was supposed to boost drug discovery, but progress has stalled. Learn why the hype hasn’t delivered and what needs to ...

The FDA has introduced Elsa, an internal AI tool to review safety data, identify labeling issues, and prioritize inspections, potentially speeding up responses to food safety issues like recalls.

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