21 U.S.C. § 360a
Clinical trial guidance for antibiotic drugs
United States · Title 21 — FOOD AND DRUGS · Status: effective
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- Citation
- 21 U.S.C. § 360a, Clinical trial guidance for antibiotic drugs, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454264
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Full text
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.
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.
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone.
- Food and Drug Administration Amendments Act of 2007House: 405–7Senate: no recorded tally