Pub. L. 117-328, div. FF, tit. III, subtit. A, sec. 3105
REAUTHORIZATION OF PROVISION PERTAINING TO DRUGS CONTAINING SINGLE ENANTIOMERS.
SEC. 3105. 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 “December 24, 2022” and inserting “October 1, 2027”.