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

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

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

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 ...

FDA staffers in the Center for Devices and Radiological Health told NBC News that their AI pilot, CDRH-GPT, is buggy, isn't connected to the Internet or the FDA's internal system, and has problems ...

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.

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

FDA’s Broader AI Goals. The launch of Elsa is part of a broader “AI-forward” strategy. In January 2025, the agency issued a draft guidance on considerations for the use of AI to support ...

On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program for scientific reviewers. 1 FDA Commissioner Marty ...

Generative artificial intelligence has found another home in the federal government. On Tuesday, the U.S. Food and Drug Administration announced the early launch of its very own generative AI that ...

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.