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GUIDANCE DOCUMENT

Complicated Urinary Tract Infections: Developing Drugs for Treatment June 2018

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2012-D-0148
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 complicated urinary tract infections (cUTIs).2 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 cUTIs.

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0148.

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