2012 U.S. Code
Title 21 - Food and Drugs
Chapter 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT (§§ 301 - 399f)
Subchapter V - DRUGS AND DEVICES (§§ 351 - 360ddd-2)
Part A - Drugs and Devices (§§ 351 - 360n-1)
Section 360a - Clinical trial guidance for antibiotic drugs
| Publication Title | United States Code, 2012 Edition, Title 21 - FOOD AND DRUGS |
| Category | Bills and Statutes |
| Collection | United States Code |
| SuDoc Class Number | Y 1.2/5: |
| Contained Within | 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 |
| Contains | section 360a |
| Date | 2012 |
| Laws in Effect as of Date | January 15, 2013 |
| Positive Law | No |
| Disposition | standard |
| Source Credit | June 25, 1938, ch. 675, §511, as added Pub. L. 110-85, title IX, §911, Sept. 27, 2007, 121 Stat. 951. |
| Statutes at Large References | 79 Stat. 227 82 Stat. 1361 84 Stat. 1281 121 Stat. 951 |
| Public Law References | Public Law 89-74, Public Law 90-639, Public Law 91-513, Public Law 110-85 |
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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) ReviewNot 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.)
Prior ProvisionsA 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.
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