human drug application
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 379G — for purposes of this subpart (9 versions over time)
The term “human drug application” means 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.
21 U.S.C. § 360bbb-4a — in this section (2 versions over time)
The term “human drug application” has the meaning given such term in section 379g(1) of this title.