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.

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

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 ...

The FDA’s AI program needs to have guardrails in place to ensure it’s working properly. No matter what AI is used for at the FDA, processes must be in place to ensure fairness and accuracy, ...

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 ...

He further added that the official launch of an AI review assistant follows "years of talks about AI capabilities.” FDA centers are now asked to fully deploy the AI tool by June 30 and have it ...

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.