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

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

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

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

AI is changing how drugs are manufactured, particularly when it comes to getting them approved. Because it is so fast at processing information, the whole appro ...

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

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 ...

FDA's Embrace of AI to Speed Up Drug Approvals Leaves Industry Observers Excited, Uneasy 6 minute read June 06, 2025. By. John Russell. Email. Share. Print. Credit: Maksim Šmeljov/Adobe Stock.

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

Traditionally, drug discovery relied heavily on trial and error, with long timelines and high costs. The introduction of ...

“If the question is, can AI replace a human reviewer, I would say absolutely not,” said Jason Conaty, counsel in the Los Angeles office of Hogan Lovells who specializes in drug regulatory affairs.