21 U.S.C. § 360A
Section 360a · Clinical trial guidance for antibiotic drugs
This is the Federal Food, Drug, and Cosmetic Act
Amended 2 times on record
Applied in 80 court decisions — leading case White v. United States (1968)
Most recently applied in Jazz Pharmaceuticals, Inc. v. Robert F. Kennedy Jr. (June 2025)
Not later than 1 year after September 27, 2007, the Secretary shall issue guidance for the conduct of clinical trials with respect to antibiotic drugs, including antimicrobials to treat acute bacterial sinusitis, acute bacterial otitis media, and acute bacterial exacerbation of chronic bronchitis. Such guidance shall indicate the appropriate models and valid surrogate markers.
Not later than 5 years after September 27, 2007, the Secretary shall review and update the guidance described under subsection (a) to reflect developments in scientific and medical information and technology.
Editorial notes U.S. Code · Office of the Law Revision Counsel
Prior Provisions
A prior section 360a, act June 25, 1938, ch. 675, §511, as added July 15, 1965, Pub. L. 89–74, §3(b), 79 Stat. 227; amended Oct. 24, 1968, Pub. L. 90–639, §2(a), 82 Stat. 1361, regulated the manufacture, compounding, and processing of depressant and stimulant drugs and their sale, delivery, disposal, possession, and recordkeeping activities connected therewith, prior to repeal by Pub. L. 91–513, title II, §§701(a), 704, Oct. 27, 1970, 84 Stat. 1281, 1284, effective on the first day of the seventh calendar month that began after Oct. 26, 1970.