### Question
What is the definition of human data studies?


### Answer
The definition of **human data studies** is as follows in *21 U.S.C. § 355h*:

> clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies

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

