sufficient quantities
Defined in 1 place of the United States Code.
the term “sufficient quantities” means an amount of a covered product that the eligible product developer determines allows it to—
(A) conduct testing to support an application under—
(i) subsection (b)(2) or (j) of section 355 of this title; or
(ii) section 262(k) of title 42; and
(B) fulfill any regulatory requirements relating to approval of such an application.
Source
- 2019–present21 U.S.C. § 355-2Food and Drugs · Actions for delays of generic drugs and biosimilar biological products · in this section