21 U.S.C. § 360a — Clinical trial guidance for antibiotic drugs

(a) In general By September 27, 2008 — one year after this law was enacted — the Secretary had to issue guidance on how to run clinical trials for antibiotic drugs. This covers antimicrobials used to treat acute bacterial sinusitis, acute bacterial ear infections (otitis media), and acute bacterial flare-ups of chronic bronchitis. The guidance had to spell out which study models were appropriate and which surrogate markers — stand-in signs used to judge whether a drug works — were valid. (b) Review By September 27, 2012 — five years after this law was enacted — the Secretary had to review the guidance from subsection (a) and update it to reflect new developments in scientific and medical information and technology.