What is the overall goal of each FDA Risk Evaluation and Mitigation Strategy?

Published Date: 
November 22, 2013

According to the FDA, the goal of REMS is to ensure that the benefits of a drug or biological product outweigh its risks. The FDA may require a REMS as part of the approval of a new product, or for an approved product when new safety information arises. A REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use. Since medicines are very different from each other, each REMS for each medicine is also different. A REMS may include a medication guide or package insert for patients and a communication plan to inform key audiences such as healthcare professionals and medical societies about the risks and safe use measures. For more information, visit www.fda.gov and see the following resources: Approved Risk Evaluation and Mitigation Strategies (REMS) and FDA Basics Webinar: A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS).

 

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