### Question
How is the "real world evidence" defined?


### Answer
The term **real world evidence** is defined in *21 U.S.C. § 355g* as follows -

> data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials

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

