July 21, 2020, Vol 324, No. 3, Pages 209-310
Use of Risk Evaluation and Mitigation Strategies by the US Food and Drug Administration, 2008-2019
Jenny S. Guadamuz, PhD; Dima M. Qato, PharmD, MPH, PhD; G. Caleb Alexander, MD, MS
JAMA. 2020;324(3):299-301. doi:10.1001/jama.2020.6611
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.