### 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)(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,


(C) initial certification or initial approval of an antibiotic drug under section 357 of this title, or


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

#### Citation:
  - *21 U.S.C. § 379g*
  - Heading: **CHAPTER 8-NARCOTIC FARMS > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 2-fees relating to drugs**

