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 ...

The Food and Drug Administration just announced that it will immediately start using AI across all of its centers, after completing a new generative AI pilot for scientific reviewers. Supposedly ...

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.

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 ...

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 In January 2025, the agency issued a draft guidance on considerations for the use of AI to support ...

The FDA has launched the generative AI tool, Elsa, agency-wide to help its employees with everything from clinical reviews to investigations. Sure, we're living in a time of widespread ...

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 ...

The FDA may be facing a 4% cut to its overall budget courtesy of the Trump administration, but that hasn’t stopped the agency from unveiling a new generative AI tool a month ahead of schedule ...

Following a successful pilot, the Food and Drug Administration unveiled its in-house large language model designed to help agency staff in drug clinical evaluations and reviews.