### Question
Can you define what REMS means?


### Answer
**REMS** is defined as the following in *21 U.S.C. § 355*:

> a risk evaluation and mitigation strategy under section 355–1 of this title

#### Citation:
  - *21 U.S.C. § 355*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

