The Food and Drug Administration is going all in on artificial intelligence. Commissioner Martin Makary, M.D., has instructed all the agency’s centers to fully integrate generative AI into their work by the end of June, the agency announced May 8.
The order follows the launch of a pilot program using generative AI for scientific reviewers, according to the announcement.
“We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process,” Makary said in the release. “The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.”
After the integration is complete, the FDA’s centers will continue work to expand the possible uses of AI to meet their specific needs, the agency said. After June 30, “all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.”
The agency plans to release more information about the AI adoption initiative in June, according to the release.
The AI rollout is being led by Jeremy Walsh, the FDA’s freshly tapped chief AI officer, and Sridhar Mantha, the director of the Office of Strategic Programs at the FDA’s Center for Drug Evaluation and Research.
Walsh announced that he’d taken the top AI job last week. In addition to AI, he will also oversee the agency’s IT operations, with a general goal of speeding up review timelines for medical products.
Walsh has hit the ground running in his new role, holding talks with OpenAI about building a ChatGPT offshoot for the FDA called cderGPT, according to a report from Wired.