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.

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

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

With the introduction of genAI tool Elsa at the FDA in June, the technology is playing a greater role in the medical device review process.

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

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 ...

The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in even more automation amid thousands of federal ...

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.

The FDA already has ways to speed up the approval process for promising drugs, such as fast track and breakthrough therapy designations. AI could add another layer of efficiency, but it must be ...