Fact Sheet

The Importance of Risk Evaluation and Mitigation Strategies

PhRMA October 23, 2017

Risk Evaluation Mitigation Strategies (REMS) are a safeguard the U.S. Food and Drug Administration (FDA) may require based on the safety profile of a new medicine or new safety information for a previously approved medicine. The purpose of a REMS is to ensure that the clinical benefits of a medicine are greater than its risks.