So in original. The period probably should be a semicolon.
Editorial Notes
References in Text

Section 101(c) of the Food and Drug Administration Amendments Act of 2007, referred to in subsec. (a)(1), is section 101(c) of Pub. L. 110–85, which is set out as a note under section 379g of this title.


2021—Subsec. (a)(4)(C). Pub. L. 117–9 amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: “is for a human drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under section 355(b)(1) of this title or section 262 of title 42.”

2017—Subsec. (a)(4)(A)(iii), (iv). Pub. L. 115–52 added cls. (iii) and (iv).

2016—Subsec. (a)(3)(Q). Pub. L. 114–146, § 2(2), substituted “Filovirus Diseases” for “Filoviruses”.

Subsec. (a)(3)(R), (S). Pub. L. 114–146, § 2(1), (3), added subpar. (R) and redesignated former subpar. (R) as (S).

Subsec. (c)(4)(A). Pub. L. 114–255 made technical amendment to reference in original act which appears in text as reference to section 262 of title 42.

2014—Subsec. (a)(3)(Q), (R). Pub. L. 113–233, § 2(1), added subpar. (Q), redesignated former subpar. (Q) as (R), and in subpar. (R) substituted “order of” for “regulation by”.

Subsec. (b)(2). Pub. L. 113–233, § 2(2)(A), inserted at end “There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.”

Subsec. (b)(4). Pub. L. 113–233, § 2(2)(B), substituted “90 days” for “365 days”.

Statutory Notes and Related Subsidiaries
Effective Date of 2017 Amendment

Pub. L. 115–52, title VI, § 611(b), Aug. 18, 2017, 131 Stat. 1054, provided that: “The amendments made by subsection (a) [amending this section] shall apply to human drug applications submitted after September 30, 2017.”