S. 4378 — Introduced in Senate

II 117th CONGRESS 2d Session S. 4378 IN THE SENATE OF THE UNITED STATES June 13, 2022Mr. 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. 1. Short title This Act may be cited as the Hatch-Waxman Improvement Act of 2022. 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.