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 ...

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

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.

But according to three current FDA employees “ELSA” is creating studies that don’t exist. They say that makes it hard to ...

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

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

MUNGKHOOD STUDIO // ShutterstockHow artificial intelligence is transforming medical imagingA decade ago, deep learning prototypes wowed conferences but rarely touched patients. By June 2025, 777 ...

The integration of artificial intelligence (AI) and machine learning (ML) in a drug development and launch playbook offers new possibilities to find the right subpopulation(s) for product ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission ...