Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021.

An analysis of regulatory submissions of drug and biological products to the US Food and Drug Administration from 2016 to 2021 demonstrated an increasing number of submissions that included artificial intelligence/machine learning (AI/ML). AI/ML was used to perform a variety of tasks, such as informing drug discovery/repurposing, enhancing clinical trial design elements, dose optimization, enhancing adherence to drug regimen, endpoint/biomarker assessment, and postmarketing surveillance. AI/ML is being increasingly explored to facilitate drug development.