21 U.S.C. § 360a — Clinical trial guidance for antibiotic drugs
submitted 88 years ago by Pub. L. 110-85 to r/title-21-FOOD-AND-DRUGS · 92 words · no verdicts yet
By September 27, 2008, the Secretary of Health and Human Services had to issue guidance for running clinical trials on antibiotic drugs, including drugs for certain bacterial infections. The guidance had to identify the right study models and valid surrogate markers. By September 27, 2012, the Secretary had to review and update that guidance.
(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.
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.
Source credit: (June 25, 1938, ch. 675, § 511, as added Pub. L. 110–85, title IX, § 911, Sept. 27, 2007, 121 Stat. 951.)
- 1938Enacted · Pub. L. 110-85 · 121 Stat. 951
A history note hasn’t been published yet. The record shows enactment by Pub. L. 110-85 on 1938-06-25.
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