STAT+: Five burning questions about FDA's 'aggressive' deployment of AI for scientific review

The Food and Drug Administration said it will rapidly roll out a generative artificial intelligence model to assist scientific reviews across the agency, setting up a high-stakes test of the technology’s use in vetting products used in the care of millions of Americans.

Calling it a “historic first,” FDA commissioner Marty Makary said on Thursday that the AI tool will be deployed across all of the agency’s review offices by the end of June, following the completion of pilot testing whose scope and rigor was unspecified.

“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 a release, which claimed the technology cut time spent on certain review tasks from three days down to minutes.

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