Key points from article :
In a major step toward modernising its internal processes, the U.S. Food and Drug Administration (FDA) has completed its first pilot using generative artificial intelligence (AI) to assist scientific reviewers. The pilot, which significantly sped up routine review tasks, was described as a "game-changer" by staff and has prompted the agency to launch a rapid, agency-wide AI rollout. FDA Commissioner Dr. Martin A. Makary announced that all FDA centres must begin deploying the new tools immediately, with full integration targeted for June 30, 2025.
The generative AI tools are designed to reduce the amount of repetitive and time-consuming work typically required of FDA scientists. In one case, a task that previously took three days was completed in minutes, highlighting the transformative potential of the technology. Dr. Makary emphasised the need to act quickly, stating that the benefits to public health and efficiency are too important to delay further.
To oversee this sweeping rollout, the FDA has appointed Jeremy Walsh as its new Chief AI Officer, alongside Sridhar Mantha, who will help coordinate implementation across centres. After the June deadline, the agency will continue improving the system by expanding its functions, increasing document integration, and tailoring outputs to each department’s specific needs—all while ensuring data security and regulatory compliance.
This initiative marks a significant moment for AI in government health agencies, moving beyond theoretical discussions to practical applications with real-world impact. The FDA plans to share further updates on the programme in June.
