### Question
How is the term qualified data summary defined?


### Answer
The term **qualified data summary** is defined in *21 U.S.C. § 355* as the following:

> a summary of clinical data that demonstrates the safety and effectiveness of a drug with respect to a qualified indication

#### 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**

