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

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

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

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

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.

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

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change ...

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

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

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