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

Jenny S Guadamuz; Dima M Qato; G Caleb Alexander

doi:10.1001/jama.2020.6611

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

JAMA. 2020 Jul 21;324(3):299-301. doi: 10.1001/jama.2020.6611.

Authors

Jenny S Guadamuz¹, Dima M Qato¹, G Caleb Alexander²

Affiliations

¹ Department of Pharmacy Systems, Outcomes and Policy, University of Illinois at Chicago College of Pharmacy.
² Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

Abstract

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.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Certification / legislation & jurisprudence
Drug Industry / legislation & jurisprudence
Drug Labeling / legislation & jurisprudence
Drug-Related Side Effects and Adverse Reactions / prevention & control*
Program Development / statistics & numerical data
Program Evaluation
Registries
Risk Evaluation and Mitigation / legislation & jurisprudence*
Time Factors
United States
United States Food and Drug Administration / legislation & jurisprudence*