Hatch-Waxman Improvement Act of 2022

S. 4378 · 117th Congress · Jun 13, 2022 · Lineage

A BILL

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

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

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”.