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sufficient quantities

Defined in 1 dictionary — U.S. Code

United States Code

21 U.S.C. § 355-2 — in this section (2 versions over time)

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.