The FDA has initiated a robust timeline for integrating artificial intelligence into its scientific review processes across 11 centers by summer 2023. Following a successful pilot, the agency, led by Commissioner Martin Makary, aims to enhance the efficiency of reviews by automating repetitive tasks. Deployed through a secured platform, the AI tool is designed to free scientists to concentrate on critical evaluations. The agency expects continuous improvements and user feedback, promising greater transparency in deployment are set for June.
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.
The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.
FDA centers are now asked to fully deploy the AI tool by June 30 and have it fully integrated into individual data platforms and networks.
Greater transparency in the deployment process, such as user feedback and performance results, will also be publicly available in June.
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