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.

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

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

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

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

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, ...

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

The FDA becomes involved before any new drug molecule is tested in humans. Here’s how upheaval at the agency appears to be affecting specific points in the approval process for new drugs.