Title 21 — Food and DrugsRelease 119-73not60
§360a Clinical Trial Guidance for Antibiotic Drugs
Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices › § 360a
Summary
By 1 year after Sept. 27, 2007, the Secretary must issue clinical-trial guidance for antibiotic uses, identify study models and valid surrogate markers, and update it within 5 years to reflect science and technology.
Full Legal Text
Title 21, §360a
Food and Drugs — Source: USLM XML via OLRC
(a)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.
(b)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.
Legislative History
Notes & Related Subsidiaries
Editorial Notes
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.
Reference
Citations & Metadata
Citation
21 U.S.C. § 360a
Title 21 — Food and Drugs
Last Updated
Apr 5, 2026
Release point: 119-73not60