The FDA completed its first AI-assisted scientific review pilot, which will provide reviewers with great opportunities for efficiency in the review process. According to the FDA release (here), Dr. Makary said, “I was blown away by the success of our first AI-assisted scientific review pilot. 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 agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.”
Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER), commented, “This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days.” His statement suggests that the AI tool will make the Agency’s reviews much more efficient by allowing reviewers to spend less time on repetitive tasks that slow down their reviews.
The rollout across all FDA centers is scheduled to be completed by June 30, 2025, which is very aggressive. It will be interesting to see how reviewers react and accept this new paradigm and how its use will speed approvals. From the first blush, it certainly seems very promising!
