FDA Complicated Urinary Tract Infections Developing Drugs for Treatment
标准简介
Complicated Urinary Tract Infections Developing Drugs for Treatment[附网盘链接]由FDA于不久前发布，适用于美国。标准截图
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标准文档说明
标准文档类型为Complicated Urinary Tract Infections Developing Drugs for Treatment[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Complicated Urinary Tract Infections:
Developing Drugs for Treatment
1
Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION The purpose of this guidance is to assist sponsors in the clinical development of drugs for the 2
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 3 Trials. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of 1
This guidance has been prepared by the Division of Anti-Infective Products in the Center for Drug Evaluation and Research at the Food and Drug Administration. You may submit comments on this guidance at any time. Submit comments to Docket No. FDA-2012-D-0148 (available at https://www.regulations.gov/docket?D=FDA-2012-D-
0148) (see the instructions for submitting comments in the docket). 2
For the purposes of this guidance, all references to drugs include both human drugs and therapeutic biological products unless otherwise specified. 3
We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. 1
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