REMS: Time to reevaluate.

The article reports on the need for the U.S. Food and Drug Administration (FDA) to reexamine the risk evaluation and mitigation strategy (REMS) for the pharmaceutical industry. Topics mentioned include some suggestions on how FDA can improve REMS program to improve patient safety, a case that highlights the importance of standardizing REMS processes, and the purpose of REMS to reduce the severity of a medication-related event.