21 USC § 360a - Clinical trial guidance for antibiotic drugs

---
identifier: "/us/usc/t21/s360a"
source: "usc"
legal_status: "official_prima_facie"
title: "21 USC § 360a - Clinical trial guidance for antibiotic drugs"
title_number: 21
title_name: "FOOD AND DRUGS"
section_number: "360a"
section_name: "Clinical trial guidance for antibiotic drugs"
chapter_number: 9
chapter_name: "FEDERAL FOOD, DRUG, AND COSMETIC ACT"
subchapter_number: "V"
subchapter_name: "DRUGS AND DEVICES"
part_number: "A"
part_name: "Drugs and Devices"
positive_law: false
currency: "119-84"
last_updated: "2026-04-17"
format_version: "1.1.0"
generator: "[email protected]"
source_credit: "(June 25, 1938, ch. 675, § 511, as added Pub. L. 110–85, title IX, § 911, Sept. 27, 2007, 121 Stat. 951.)"
---


# § 360a. Clinical trial guidance for antibiotic drugs

**(a)** **In general** September 27, 2007

Not later than 1 year after , 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)** **Review** September 27, 2007

Not later than 5 years after , the Secretary shall review and update the guidance described under subsection (a) to reflect developments in scientific and medical information and technology.

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**Source Credit**: (June 25, 1938, ch. 675, § 511, as added Pub. L. 110–85, title IX, § 911, Sept. 27, 2007, 121 Stat. 951.)

## Editorial Notes

### Prior Provisions

A prior section 360a, , as added , , ; amended , , , 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 , §§ 701(a), 704, , , 1284, effective on the first day of the seventh calendar month that began after .