PRIA, Government Policy, Made Personal

Summary

The Secretary must issue guidance within 1 year after September 27, 2007 on how to run clinical trials for antibiotic drugs. The guidance must say which trial designs to use and what reliable substitute measurements are acceptable. It must cover antibiotics for acute bacterial sinus infections, middle ear infections, and sudden worsening of chronic bronchitis. The Secretary must review and update that guidance within 5 years after September 27, 2007 to reflect new scientific and medical developments.

Title 21, §360a

Food and Drugs, Source: USLM XML via OLRC

(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.

Notes & Related Subsidiaries

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.

§360a Clinical Trial Guidance for Antibiotic Drugs

Summary

Title 21, §360a

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

Citations & Metadata