### Question
How is the "substantial evidence" defined?


### Answer
The term **substantial evidence** is defined in *21 U.S.C. § 360b* as follows -

> evidence consisting of one or more adequate and well controlled investigations, such as—


(A) a study in a target species

#### Citation:
  - *21 U.S.C. § 360b*
  - Heading: **CHAPTER 8-NARCOTIC FARMS > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

