### Question
How does DRUGS AND DEVICES define phase 1 trial?


### Answer
Under *21 U.S.C. § 360bbb*, **phase 1 trial** is defined as:

> a phase 1 clinical investigation of a drug as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations)

#### Citation:
  - *21 U.S.C. § 360bbb*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part E-General Provisions Relating to Drugs and Devices**

