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 ...

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

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

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

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

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

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

FDA's Embrace of AI to Speed Up Drug Approvals Leaves Industry Observers Excited, Uneasy 6 minute read June 06, 2025. By. ... Already, they can seek expedited approval pathways, ...