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The law › Title 21, Food and Drugs › Chapter 9

21 U.S.C. 360n: Priority review to encourage treatments for tropical diseases

Created in 2007 by the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85). Changed by 5 later laws. No bill we track in this Congress changes it.

This Congress

No bill we track in the 119th Congress changes this section.

    How it got here

    2021

    • 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 titl… Law text · (a)

    2017

    • Pub. L. 115–52 added cls. (iii) and (iv). (FDA Reauthorization Act of 2017) Law text · (a), (iv)

    2016

    • Pub. L. 114–146, §2(2), substituted "Filovirus Diseases" for "Filoviruses". Law text · (a)
    • Pub. L. 114–146, §2(1), (3), added subpar. (R) and redesignated former subpar. (R) as (S). Law text · (a), (S)
    • Pub. L. 114–255 made technical amendment to reference in original act which appears in text as reference to section 262 of title 42. (21st Century Cures Act) Law text · (c)

    2014

    • 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". Law text · (a), (R)
    • 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." Law text · (b)
    • Pub. L. 113–233, §2(2)(B), substituted "90 days" for "365 days". Law text · (b)

    Text, outline and history from the official U.S. Code (2024 edition) on GovInfo, published by the Office of the Law Revision Counsel. Changes made after that edition appear under This Congress.