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# FDA Issues Draft uUTI Guidance
- URL: https://www.fdaweb.com/fda-issues-draft-uuti-guidance/
- Published: 2018-05-09T12:00:00.000Z
- Updated: 2026-09-15T00:04:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141393

FDA has issued a draft guidance to assist sponsors in the clinical development of drugs to treat uncomplicated urinary tract infections (uUTI). The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM607095.pdf?ref=fdaweb.com) specifically addresses the agency’s current thinking on the overall development program and clinical trial designs for drugs to serve as a focus for continued discussions among the CDER Division of Anti-Infective Products, drug sponsors, the academic community, and the public.

The guidance says FDA considers treatment of uUTIs to be an indication distinct from treating complicated urinary tract infections (cUTIs), and the guidance addresses only uUTIs. A separate guidance has been issued for cUTI drug development.

Contents of the guidance include an Introduction, Background, Development Program with general considerations and specific efficacy trial considerations, and References and an Appendix.