The U.S. Food and Drug Administration (FDA) has said that it will scale the use of artificial intelligence across its 11 centers by early summer after successfully piloting a new tool for research purposes.
The agency announced on May 8 that it is employing an “aggressive timeline” to deploy by June 30 a finalized AI tool used to streamline research review processes for FDA scientists and subject-matter experts.
“I was blown away by the success of our first AI-assisted scientific review pilot,” said FDA Commissioner Martin Makary in a statement. “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.”
The FDA said the tool will operate on a “common, secure generative AI system” that is linked to the FDA’s internal data platforms.
Makary said he has directed all FDA centers to deploy the new technology immediately and plans to expand use cases, improve functionality, and “adapt to the evolving needs of each center” after the June 30 timeline.
The tool’s launch comes after “years of talk about AI capabilities,” according to Makary, who added that it is “time to take action.”
In the future, the agency said that it will expand generative AI capabilities on a single unified platform, and that future updates will zero in on improving usability, expanding document integration, and tailoring outputs to center-specific needs, while maintaining strict information security and compliance with agency policies.
The AI rollout will be spearheaded by Jeremy Walsh, the FDA’s new chief AI officer, and Sridhar Mantha, the director of FDA’s Office of Strategic Programs.
Feedback gathered from users will be used to refine features and assess the technology throughout its deployment. The agency plans to share more details about the initiative in June.