The US Food and Drug Administration (FDA) announced plans to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, following the completion of a new generative AI pilot for scientific reviewers.
The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.
“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,” says FDA commissioner Martin A. Makary, MD, MPH, in a release.
Future enhancements will focus on improving usability, expanding document integration, and tailoring outputs to center-specific needs, while maintaining strict information security and compliance with FDA policy.
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