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 ...

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

The Food and Drug Administration's new AI tool, Elsa, is reportedly generating false studies, raising concerns about the ...

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

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

U.S. Food and Drug Administration employees told CNN that Elsa — the AI model that’s supposed to help speed up approvals of pharmaceuticals and medical devices — isn’t working great. Instead, it cites ...

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

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump ...

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

While the FDA is not commenting about how far it might use AI tools in speeding up the drug and device review process, some experts say that the agency so far seems to be focusing on ...