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.
June 25, 1938, ch. 675, § 511Pub. L. 110–85, title IX, § 911121 Stat. 951(, as added , , .)
Editorial Notes
Prior Provisions
act June 25, 1938, ch. 675, § 511Pub. L. 89–74, § 3(b)79 Stat. 227Pub. L. 90–639, § 2(a)82 Stat. 1361Pub. L. 91–513, title II84 Stat. 1281A prior section 360a, , as added , , ; amended , , , 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 , §§ 701(a), 704, , , 1284, effective on the first day of the seventh calendar month that began after .