SEC. 511. [21 USC §360a] Clinical Trial Guidance for Antibiotic Drugs

Note: This section was added in February 2008.

(a) In general. Not later than 1 year after the date of the enactment of this section [enacted Sept. 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 the date of the enactment of this section [enacted Sept. 27, 2007], the Secretary shall review and update the guidance described under subsection (a) to reflect developments in scientific and medical information and technology.