Application of Machine Learning in Drug Development and Regulation: Current Status and Future Potential

Machine learning (ML), a field of data science with over 50 years of history, has gained momentum in the past decade due to the intersection of powerful computing tools and the increased availability of large data sets. Herein, we provide an overview of a sample of ML algorithms and describe areas where ML has been used to support drug development and regulatory submissions to the US Food and Drug Administration (FDA), as well as to facilitate review and research.