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21 U.S.C. 355f: Extension of exclusivity period for new qualified infectious disease products

Created in 2012 by the Food and Drug Administration Safety and Innovation Act (Public Law 112-144). Changed by 1 later law. No bill we track in this Congress changes it.

7 other sections of the Code cite this one, including 21 U.S.C. 353, 21 U.S.C. 355, 21 U.S.C. 355a, 21 U.S.C. 356, 21 U.S.C. 360a–1.

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, §3212(a)(1), added par. (4). (Consolidated Appropriations Act, 2023) Law text · (c)
    • Pub. L. 117–328, §3212(a)(2), inserted "or section 262(a) of title 42" after "section 355(b) of this title". (Consolidated Appropriations Act, 2023) Law text · (d)
    • Pub. L. 117–328, §3212(a)(3), amended subsec. (g) generally. Prior to amendment, text read as follows: "The term 'qualified infectious disease product' means an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caus… (Consolidated Appropriations Act, 2023) Law text · (g)

    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.