30 May 2024 - The US FDA plans to release a draft guidance this year on the use of artificial intelligence/machine learning (AI/ML) to support drug development. 

The guidance will be informed by the agency’s experience in reviewing submissions containing AI/ML elements, as well as feedback it received on two discussion papers on the topic released last year, said Tala Fakhouri, associate director for policy analysis in the Office of Medical Policy at FDA’s Center for Drug Evaluation and Research.

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