### Question
Can you define what new human data studies means?


### Answer
**New human data studies** is defined as the following in *21 U.S.C. § 355h*:

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


(I) have not been relied on by the Secretary to support—


(aa) a proposed or final determination that a drug described in subclause (I), (II), or (III) of clause (iii) is generally recognized as safe and effective under section 321(p)(1) of this title

#### 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**

