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

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

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

The federal agency introduced Elsa last month, boasting about the AI tool's ability to increase efficiency at the FDA.

Hallucinations are a known problem with generative AI models—and Elsa is no different, according to Jeremy Walsh, the head of ...

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

Meanwhile, FDA Commissioner Marty Makary highlighted the speed with which the tool was rolled out. "I set an aggressive timeline to scale AI agency-wide by June 30," Makary said.

And according to Robert Califf, who served as FDA commissioner between 2016 and 2017, the agency review teams have already been experimenting with AI for several years.

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

May 8 (UPI) -- The Food and Drug Administration on Thursday announced what it called an aggressive agency-wide artificial intelligence adoption timeline, as well as a new AI tool to help ...

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool ...

The U.S. Food and Drug Administration (FDA) has approved the first artificial intelligence (AI) tool to predict breast cancer risk. The authorization was confirmed by digital health tech company ...