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

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

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

Hallucinations are a known problem with generative AI models—and Elsa is no different, according to Jeremy Walsh, the head of ...

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

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

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

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

Following the lead of other federal agencies, the FDA has announced a plan to incorporate AI soon. It could speed up drug approvals, but it's controversial.

FDA officials want to leverage AI for drug and device approval, animal testing, and data processing, as the Trump administrations slashes its workforce.

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 In January 2025, the agency issued a draft guidance on considerations for the use of AI to support ...

The success of the AI review pilot program has prompted FDA Commissioner Martin Makary, M.D., M.P.H., to direct all FDA product centers to immediately begin deployment of AI-based scientific ...