FDA Incorporates AI Technology to Accelerate Drug and Food Safety Assessments

The U.S. Food and Drug Administration (FDA) is exploring innovative approaches to expedite the approval process for new pharmaceuticals and medical devices by utilizing artificial intelligence (AI). Announced on June 10, 2025, this initiative aims to reduce the lengthy review periods that currently can extend over months or even years. AI tools, such as a model named Elsa—analogous to ChatGPT—are being developed to assist in analyzing safety data, summarizing reports, and identifying facilities requiring inspections.

According to officials, integrating AI could streamline various aspects of the review process, allowing the FDA to evaluate large volumes of data more efficiently. Elsa is capable of processing up to 500,000 pages of submitted information, potentially drastically shortening approval timelines. However, challenges exist; some FDA staff have reported that Elsa occasionally produces incorrect responses, termed "hallucinations," necessitating double checks. Additionally, its capacity to handle extensive datasets and time-saving effectiveness remains limited at this stage.

The FDA's leadership, including Commissioner Dr. Marty Makary and Dr. Vinay Prasad of the vaccine and gene therapy division, emphasize the goal of delivering faster treatments and cures, particularly for patients with neglected and rare diseases. They also plan to scrutinize potentially harmful ingredients in U.S. foods—such as artificial dyes and chemicals—which may not be permitted in other countries, conducting re-evaluations of the benefit-to-harm ratios.

Despite promising potentials, some experts express caution. Stephen Holland, a former health advisor to Congress, and Dr. Reshma Ramachandran from Yale University, have raised concerns about the real-world effectiveness of these AI tools and the risk of regulatory relationships becoming too close to industry, which could undermine the integrity of approval processes.

The agency faces ongoing staffing challenges, having reduced its workforce to about 8,000, with fewer resources than during the pandemic. Nevertheless, the FDA remains committed to accelerating access to essential treatments, aiming to mirror the rapid review capabilities seen during initiatives like Operation Warp Speed.

For further details, consult the original publication in the Journal of the American Medical Association: Link. Source: https://medicalxpress.com/news/2025-06-fda-ai-drug-food-safety.html