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 ...

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.

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.

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

Following the lead of other federal agencies, the FDA has announced a plan to incorporate AI soon. It could speed up drug approvals, but it's controversial.

A new Food and Drug Administration AI tool that could speed up reviews and approvals of medical devices such as pacemakers and insulin pumps is struggling with simple tasks, according to two ...

FDA Commissioner Dr. Martin Makary has directed each product center (drugs, devices, biologics, and others) to begin immediate deployment of generative AI tools. By June 30, 2025, FDA expects all ...

The FDA has introduced Elsa, an internal AI tool to review safety data, identify labeling issues, and prioritize inspections, potentially speeding up responses to food safety issues like recalls.