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


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

> an application for—


(A) approval of a new drug submitted under section 355(b)(1) of this title,


(B) approval of a new drug submitted under section 355(b)(2) of this title after September 30, 1992, which requests approval of—


(i) a molecular entity which is an active ingredient (including any salt or ester of an active ingredient), or


(ii) an indication for a use,


  

that had not been approved under an application submitted under section 355(b) of this title, or


(C) licensure of a biological product under 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**

