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Senate Bill 4378
117th Congress(2021-2022)
Hatch-Waxman Improvement Act of 2022
Introduced
Introduced
Introduced in Senate on Jun 13, 2022
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Introduced in Senate 
Jun 13, 2022
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Introduced in Senate(Jun 13, 2022)
Jun 13, 2022
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S. 4378 (Introduced-in-Senate)


117th CONGRESS
2d Session
S. 4378


To reauthorize a provision of the Federal Food, Drug, and Cosmetic Act pertaining to drugs containing single enantiomers.

IN THE SENATE OF THE UNITED STATES

June 13, 2022

Mr. Marshall introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To reauthorize a provision of the Federal Food, Drug, and Cosmetic Act pertaining to drugs containing single enantiomers.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. Short title.

This Act may be cited as the “Hatch-Waxman Improvement Act of 2022”.

SEC. 2. Reauthorization of provision pertaining to drugs containing single enantiomers.

Section 505(u) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(u)) is amended—

(1) in paragraph (1)(A)(ii)(II), by adding “(other than bioavailability studies)” after “any clinical investigations”; and

(2) in paragraph (4), by striking “October 1, 2022” and inserting “October 1, 2027”.