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GUIDANCE DOCUMENT

Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry August 2019

Final
Docket Number:
FDA-2018-D-1562
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of uncomplicated urinary tract infections (uUTIs). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for the treatment of uUTIs.

We consider the treatment of uUTIs to be an indication distinct from the treatment of complicated urinary tract infections (cUTIs). This guidance addresses uUTIs only. The FDA issued a separate guidance on cUTIs. This guidance does not contain discussion of the general issues of statistical analysis or clinical trial design. Those topics are addressed in the ICH guidances for industry E9 Statistical Principles for Clinical Trials (September 1998) and E10 Choice of Control Group and Related Issues in Clinical Trials (May 2001), respectively.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1562.

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