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

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

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

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

In a breakthrough for cardiovascular medicine, researchers have harnessed artificial intelligence to discover unexpected ...

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

The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in even more automation amid thousands of federal ...

Researchers from Southern Medical University and collaborators report the identification of FDA‑approved compounds that may ...

The FDA already has ways to speed up the approval process for promising drugs, such as fast track and breakthrough therapy designations. AI could add another layer of efficiency, but it must be ...

While the FDA is not commenting about how far it might use AI tools in speeding up the drug and device review process, some experts say that the agency so far seems to be focusing on ...

The U.S. Food and Drug Administration (FDA) has introduced “Elsa,” a generative AI tool designed to enhance the efficiency of its regulatory operations.

The FDA becomes involved before any new drug molecule is tested in humans. Here’s how upheaval at the agency appears to be affecting specific points in the approval process for new drugs.