Following the success of a recent AI-assisted scientific review pilot, the US Food and Drug Administration (FDA)
has announced a sweeping plan to fully integrate artificial intelligence across the agency within the next 52 days.
FDA Commissioner Martin A. Makary described the move as “historic” in an announcement on Thursday, instructing all FDA centers to begin immediate deployment. The goal is to complete full integration by the end of June.
The overhaul will bring all fourteen FDA centers onto a shared, secure generative AI platform that connects with the agency’s internal data systems. According to the FDA, the initiative aims to expand use cases, enhance performance, and adapt to the distinct needs of each center.
This rapid rollout was prompted by the success of a pilot program where FDA scientists used AI tools to streamline the scientific review process. The tools helped reduce time spent on repetitive tasks that often delay drug approval, which currently takes between six to ten months after an application is submitted.
Dr. Jinzhong (Jin) Liu, Deputy Director of the FDA’s Offices of Drug Evaluation Sciences and New Drugs, described the technology as a “game changer,” noting that tasks which once took three days could now be completed in minutes.
Commissioner Makary praised the pilot’s results and emphasized the importance of acting now. “We need to respect our scientists’ time and eliminate the unproductive tasks that have long slowed the review process. This agency-wide AI deployment has the potential to dramatically speed up the approval of new therapies,” he said. “There has been enough talk about AI in theory and at conferences. It is time to take action. The ability to reduce multi-day tasks to mere minutes is too valuable to delay.”
Future enhancements will include improving usability, expanding the range of integrated documents, and tailoring outputs to the specific needs of each center. The FDA also stressed that information security and compliance with agency policies will remain top priorities.
The rollout will be overseen by Jeremy Walsh, the FDA’s newly appointed Chief AI Officer, and Sridhar Mantha, Director of Strategic Programs at the FDA’s Center for Drug Evaluation and Research (CDER).
The FDA said it will continue to evaluate system performance, collect staff feedback, and refine the AI tools as needed to support its public health mission. More information and updates are expected to be shared with the public in June.
Found this article interesting? Follow us on X(Twitter) ,Threads and FaceBook to read more exclusive content we post.
