### Question
How is the "human drug application" defined?


### Answer
The term **human drug application** is defined in *21 U.S.C. § 379g* as follows -

> an application for—


(A) approval of a new drug submitted under section 355(b) of this title, or


(B) licensure of a biological product under subsection (a) of section 262 of title 42

#### Citation:
  - *21 U.S.C. § 379g*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 2-fees relating to drugs**

