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# Guidance on Complicated Urinary Tract Infection Drugs
- URL: https://www.fdaweb.com/guidance-on-complicated-urinary-tract-infection-drugs/
- Published: 2018-06-01T12:00:00.000Z
- Updated: 2026-09-15T00:09:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141583

FDA has released a [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070981.pdf?ref=fdaweb.com) on “Complicated Urinary Tract Infections (cUTIs): Developing Drugs for Treatment.” The document discusses the overall development program and clinical trial designs for drugs to support an indication for treating cUTIs. “We consider the treatment of cUTIs to be an indication distinct from the treatment of uncomplicated urinary tract infections,” the agency says. The guidance addresses cUTI only, and sponsors interested in pursuing an indication for treating uncomplicated urinary tract infections should discuss clinical development plans with FDA. It also does not contain discussion of the general issues of statistical analysis or clinical trial design.