21 U.S.C. § 360a
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§ 360a. Clinical trial guidance for antibiotic drugs
- (a) 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) 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.
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