[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4378 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 4378

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


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                   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''.
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