### Question
What does signal of a serious risk mean?


### Answer
**Signal of a serious risk** has the following meaning in *21 U.S.C. § 355*:

> information related to a serious adverse drug experience associated with use of a drug and derived from—


(A) a clinical trial

#### 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**

