### Question
What does human drug application mean?


### Answer
**Human drug application** has the following meaning in *21 U.S.C. § 379g*:

> 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) or (k) 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**

