Title 21 — Food and Drugs
Part A · Chapter 9 — Federal Food, Drug, and Cosmetic Act
§ 360a. Clinical trial guidance for antibiotic drugs
Statutory text
In general
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.
Review
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.
Legislative history
Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.
Food and Drug Administration Amendments Act of 2007
Pub. L. 110–85 title IX § 911 · 121 Stat. 823
Enacted · 21 U.S.C. § 360a
(June 25, 1938, ch. 675, § 511, as added Pub. L. 110–85, title IX, § 911, Sept. 27, 2007, 121 Stat. 951.)
Source evidence
Code source credit
(June 25, 1938, ch. 675, § 511, as added Pub. L. 110–85, title IX, § 911, Sept. 27, 2007, 121 Stat. 951.)Enacted provision · exact public law section
SEC. 911. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS. Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 510 the following: “SEC. 511. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS. “(a) In General.— Not later than 1 year after the date of the enactment of this section, 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 the date of the enactment of this section, the Secretary shall review and update the guidance described under subsection (a) to reflect developments in scientific and medical information and technology.” .
1 of 1 references resolved to an enrolled provision
Editorial Notes
Prior Provisions
A prior section 360a, act June 25, 1938, ch. 675, § 511, as added , Pub. L. 89–74, § 3(b), 79 Stat. 227; amended , 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, , 84 Stat. 1281, 1284, effective on the first day of the seventh calendar month that began after .
Credits
(June 25, 1938, ch. 675, § 511, as added Pub. L. 110–85, title IX, § 911, , 121 Stat. 951.)