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FDA Harnesses AI To Turbocharge Safety Checks

The U.S. Food and Drug Administration (FDA) is preparing to integrate artificial intelligence into its regulatory processes in an effort to accelerate the approval of new drugs and medical devices. This initiative, outlined in a June 10 JAMA article, reflects the agency’s broader push to deliver treatments more quickly—particularly for rare or overlooked diseases—while also enhancing food safety and rebuilding public confidence.

Central to this effort is a new AI system called Elsa, which functions similarly to ChatGPT. Elsa is designed to assist with tasks such as reviewing safety data, summarizing complex reports, and identifying facilities that may need inspection. With drug application reviews often requiring months or even years, the agency believes tools like Elsa could significantly reduce turnaround times by processing large volumes of information—up to half a million pages, according to the FDA.

Despite its promise, Elsa still has limitations. Some FDA personnel have reported that the AI occasionally produces inaccurate information—a phenomenon known as “hallucination”—and struggles with handling very large datasets. While Elsa may not currently save much time, officials remain optimistic that these technologies could eventually streamline final approval stages to just a few weeks, much like the expedited processes seen during the COVID-19 pandemic.

In addition to AI integration, the FDA plans to reevaluate food safety regulations, particularly ingredients banned in other countries but still permitted in the U.S. The article called for a reassessment of the risks and benefits of food additives, such as artificial dyes and chemical preservatives, emphasizing a more health-conscious approach.

Some experts remain skeptical of the agency’s plans, citing concerns over transparency and industry influence. Critics have pointed out the FDA’s ongoing private meetings with pharmaceutical executives and worry that these actions may compromise regulatory integrity. At the same time, staffing shortages—nearly 2,000 fewer workers since the pandemic—could challenge the FDA’s capacity to implement its ambitious goals. Nevertheless, the agency continues to pursue faster, more efficient pathways to bring critical treatments to patients in need.