Use of Risk Evaluation and Mitigation Strategies by the US Food and Drug Administration, 2008-2019.

This study uses publicly available FDA.gov data to characterize trends in the US Food and Drug Administration’s use of Risk Evaluation and Mitigation Strategy (REMS) programs between 2008 and 2019 and to describe the number and classes of medications included, the strategies deployed, and the risks the program was intended to mitigate.