In a bold move to modernize regulatory processes, the Food and Drug Administration is rapidly implementing artificial intelligence across all its centers, with full integration mandated by June 30, 2025.
FDA Commissioner Martin A. Makary announced the aggressive timeline following what he described as a remarkably successful generative AI pilot for scientific reviewers. "I was blown away by the success of our first AI-assisted scientific review pilot," Makary stated. "We need to value our scientists' time and reduce the amount of non-productive busywork that has historically consumed much of the review process."
The pilot demonstrated significant efficiency gains, with one reviewer reporting that AI completed in six minutes what would normally take two to three days. The technology helps FDA scientists process vast amounts of regulatory data, synthesize documentation, and produce summaries—automating tedious, repetitive tasks that often slow down reviews.
By the June deadline, all FDA centers will operate on a common, secure generative AI system integrated with the agency's internal data platforms. The agency-wide rollout is being coordinated by Jeremy Walsh, the FDA's newly appointed Chief AI Officer, and Sridhar Mantha, a former director in the Center for Drug Evaluation and Research.
Industry reaction has been mixed. While pharmaceutical companies generally welcome potential acceleration of review timelines, questions remain about data security, model validation, and how AI-assisted decisions will be overseen. The Pharmaceutical Research and Manufacturers of America (PhRMA) expressed cautious optimism, noting that "harnessing AI requires a thoughtful and risk-based approach with patients at the center."
After the June 30 implementation, the FDA plans to continue expanding AI capabilities, improving usability, and tailoring outputs to center-specific needs. The initiative represents a significant shift from theoretical discussions about AI in government to concrete implementation, potentially serving as a model for other regulatory bodies worldwide.