### Question
How is the "serious risk" defined?


### Answer
The term **serious risk** is defined in *21 U.S.C. § 355* as follows -

> a risk of a serious adverse drug experience

#### 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**

