FDA: Complicated Urinary Tract Infections: Developing Drugs for Treatment, Guidance for Industry

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (cUTIs). 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. We consider the treatment of cUTIs to be an indication distinct from the treatment of uncomplicated urinary tract infections. This guidance addresses cUTI only. Sponsors interested in pursuing an indication for the treatment of uncomplicated urinary tract infections should discuss clinical development plans with the FDA. 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 and E10 Choice of Control Group and Related Issues in Clinical Trials.