Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.

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

Current and former members of the FDA told CNN about issues with the Elsa generative AI tool unveiled by the federal agency last month. Three employees said that in practice, Elsa has hallucinated ...

Earlier this year, the FDA unveiled Elsa, an artificial intelligence tool that's expected to speed up the process for ...

A new artificial intelligence model can improve the process of drug and vaccine discovery by predicting how efficiently ...

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...

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

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

U.S. Food and Drug Administration employees told CNN that Elsa — the AI model that’s supposed to help speed up approvals of pharmaceuticals and medical devices — isn’t working great. Instead, it cites ...

Current law does not really define the FDA’s powers to regulate devices that depend on advances in artificial intelligence and machine learning, as applied to health care.

The FDA needs to set standards for using artificial intelligence in drug development. By Charles K. Fisher Nov. 7, 2019. Reprints. Dom Smith/STAT.

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission ...