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21 U.S.C. · Food and Drugs
21 U.S.C. § 360a

Clinical trial guidance for antibiotic drugs

Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
Title 21 U.S.C. ● ACTIVE Primary Source Ch. 9
Statutory Text

21 U.S.C. § 360a — Clinical trial guidance for antibiotic drugs

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part A - Drugs and Devices Sec. 360a - Clinical trial guidance for antibiotic drugs From the U.S. Government Publishing Office, www.gpo.gov

§360a. Clinical trial guidance for antibiotic drugs

(a) In general 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) Review 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.

(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, 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.

Source: uscode.house.gov — public domain Official Source ↗
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21 U.S.C. § 360a
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The statutory text of 21 U.S.C. § 360a is reproduced from the official United States Code as published by the Office of the Law Revision Counsel of the U.S. House of Representatives (uscode.house.gov).
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← 21 U.S.C. § 360 21 U.S.C. § 360a1 →
Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
21 U.S.C. § 30121 U.S.C. § 32121 U.S.C. § 321a21 U.S.C. § 321b21 U.S.C. § 321c21 U.S.C. § 321d21 U.S.C. § 33121 U.S.C. § 33221 U.S.C. § 33321 U.S.C. § 333a21 U.S.C. § 33421 U.S.C. § 33521 U.S.C. § 335a21 U.S.C. § 335b21 U.S.C. § 335c21 U.S.C. § 33621 U.S.C. § 33721 U.S.C. § 337a21 U.S.C. § 34121 U.S.C. § 34221 U.S.C. § 34321 U.S.C. § 343121 U.S.C. § 343221 U.S.C. § 343321 U.S.C. § 343a21 U.S.C. § 34421 U.S.C. § 34521 U.S.C. § 34621 U.S.C. § 346a21 U.S.C. § 346b
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