### Question
How is the term adverse drug experience defined?


### Answer
The term **adverse drug experience** is defined in *21 U.S.C. § 355* as the following:

> any adverse event associated with the use of a drug in humans, whether or not considered drug related, including—


(A) an adverse event occurring in the course of the use of the drug in professional practice

#### 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**

