WHAT THE LAW DOINCongress, in plain words

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

21 U.S.C. 356: Expedited approval of drugs for serious or life-threatening diseases or conditions

Created in 1997 by the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115). Changed by 3 later laws. No bill we track in this Congress changes it.

12 other sections of the Code cite this one, including 21 U.S.C. 331, 21 U.S.C. 355, 21 U.S.C. 356–1, 21 U.S.C. 356–2, 21 U.S.C. 356b.

3 parts of federal rules cite it as their authority, written by Food and Drug Administration, Department of Health and Human Services (3).

This Congress

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

    How it got here

    2022

    • Pub. L. 117–328, §3210(a)(1)(A), (B), (D), designated existing provisions as subpar. (A), inserted heading, redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A) and realigned margins, and added subpars. (B) to (D). (Consolidated Appropriations Act, 2023) Law text · (c)
    • Pub. L. 117–328, §3210(a)(1)(C), substituted "an appropriate postapproval study or studies" for "appropriate postapproval studies". (Consolidated Appropriations Act, 2023) Law text · (c)
    • Pub. L. 117–328, §3210(a)(2)(B), (C), (F), designated existing provisions as subpar. (A), inserted heading, redesignated former subpars. (A) to (D) as cls. (i) to (iv), respectively, of subpar. (A) and realigned margins, and added subpar. (B). (Consolidated Appropriations Act, 2023) Law text · (c)
    • Pub. L. 117–328, §3210(a)(2)(A), substituted "described in subparagraph (B)" for "(as prescribed by the Secretary in regulations which shall include an opportunity for an informal hearing)" in introductory provisions. (Consolidated Appropriations Act, 2023) Law text · (c)
    • Pub. L. 117–328, §3210(a)(2)(D), substituted "product with due diligence, including with respect to conditions specified by the Secretary under paragraph (2)(C)" for "drug with due diligence". (Consolidated Appropriations Act, 2023) Law text · (c)
    • Pub. L. 117–328, §3210(a)(2)(E), inserted "shown to be" after "product is not". (Consolidated Appropriations Act, 2023) Law text · (c)

    2016

    • Pub. L. 114–255, §3033(a)(1), transferred subsec. (e) to appear before subsec. (f). (21st Century Cures Act) Law text · (e)
    • Pub. L. 114–255, §3033(c), inserted "and the 21st Century Cures Act" after "Food and Drug Administration Safety and Innovation Act". (21st Century Cures Act) Law text · (e)
    • Pub. L. 114–255, §3033(a)(2), added subsec. (g). (21st Century Cures Act) Law text · (g)
    • Pub. L. 114–255, §3042, added subsec. (h). (21st Century Cures Act) Law text · (h)

    2012

    • Pub. L. 112–144, §901(b), amended section generally. Prior to amendment, section consisted of subsecs. (a) to (d) relating to designation of drugs as fast track products, approval of applications for fast track products, review of incomplete applications for approval of fast track products, and awa… (Food and Drug Administration Safety and Innovation Act) Law text
    • Pub. L. 112–144, §902(a)(3), added subsec. (a). Former subsec. (a) redesignated (b). (Food and Drug Administration Safety and Innovation Act) Law text · (a)
    • Pub. L. 112–144, §803, amended subsec. (a)(1), as amended by Pub. L. 112–144, §901(b), by inserting ", or if the Secretary designates the drug as a qualified infectious disease product under section 355f(d) of this title" after "such a disease or condition". (Food and Drug Administration Safety and Innovation Act) Law text · (a)
    • Pub. L. 112–144, §902(a)(1), redesignated subsecs. (a) to (c) as (b) to (d), respectively. Former subsec. (d) relating to awareness efforts redesignated (f). (Food and Drug Administration Safety and Innovation Act) Law text · (b), (c), (d)
    • Pub. L. 112–144, §902(a)(2), which directed the redesignation of subsec. (d) as (f), was executed by redesignating the subsec. (d) relating to awareness efforts as (f), to reflect the probable intent of Congress and the subsequent amendment by Pub. L. 114–255, §3033(a)(1), which transf… (Food and Drug Administration Safety and Innovation Act) Law text · (f)
    • Pub. L. 112–144, §902(a)(4), substituted "applicable to breakthrough therapies, accelerated approval, and" for "applicable to accelerated approval". (Food and Drug Administration Safety and Innovation Act) Law text · (f)

    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.