§ 360a. Clinical trial guidance for antibiotic drugs
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/usc/title-21/section-360aA research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.)
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Cited by 35 sections · top 21
U.S. Code
public-private-law
statutes-at-large
- Public Law 90–636
- Public Law 90–640
- Public Law 110–85To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes
- Public Law 114–255To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes
register
statute-compilations
bill
- Sec. 3Susceptibility test interpretive criteria for microbial organisms
- Sec. 3Susceptibility test interpretive criteria for microorganisms
- Sec. 2122Susceptibility test interpretive criteria for microorganisms
- Sec. 2122Susceptibility test interpretive criteria for microorganisms
- Sec. 2122Susceptibility test interpretive criteria for microorganisms
- Sec. 2122Susceptibility test interpretive criteria for microorganisms
- Sec. 3Susceptibility test interpretive criteria for microbial organisms
- Sec. 3044Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices
10 references not yet in our index
- June 25, 1938, ch. 675, § 511
- Pub. L. 110–85, title IX, § 911
- 121 Stat. 951
- act June 25, 1938, ch. 675, § 511
- Pub. L. 89–74, § 3(b)
- 79 Stat. 227
- Pub. L. 90–639, § 2(a)
- 82 Stat. 1361
- Pub. L. 91–513, title II
- 84 Stat. 1281
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§ 360a
Clinical trial guidance for antibiotic drugs
Bills×15
U.S.C.×13
Stat.×4
Pub. L.×1
Fed. Reg.×1
Stat. Comp.×1
ActJune 25, 1938, ch. 675, § 511
Pub. L.Pub. L. 110–85, title IX, § 911
Stat.121 Stat. 951
Actact June 25, 1938, ch. 675, § 511
Pub. L.Pub. L. 89–74, § 3(b)
Cites 10 · showing 5Cited by 35 across 6 sources