Risk Evaluation and Mitigation

**Definition:** Strategies required by the US Food and Drug Administration (FDA) Amendments Act of 2007 when a question exists as to whether the benefits of a drug outweigh its risks. These constitute a safety plan with several potential components, including a medication guide, a communication plan, elements to ensure safe use and an implementation system to help guide the prescribers, pharmacists and patients.

**Tree numbers:** - N04.452.871.758 - N06.850.505.715.750