FDA Bacterial Vaginosis Developing Drugs for Treatment Guidance for Industry
标准简介
Bacterial Vaginosis Developing Drugs for Treatment Guidance for Industry[附网盘链接]是于不久前发布的FDA标准，适用于US。标准截图
![Bacterial Vaginosis Developing Drugs for Treatment Guidance for Industry[附网盘链接]](/img/20210914103559wjr53.jpg)
标准文档说明
标准文档类型为Bacterial Vaginosis Developing Drugs for Treatment Guidance for Industry[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
Bacterial Vaginosis: 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 overall development program and clinical trial designs to support development of topical and systemic drugs and biological 2
products for the treatment of bacterial vaginosis (BV). This guidance focuses on considerations that are specific to BV drug development. 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 3
Clinical Trials (May 2001), respectively. 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 the word should in Agency guidances means that something is suggested or recommended, but not required. 1
This guidance has been prepared by the Division of Anti-Infective Products in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2
For purposes of this guidance, references to drugs includes drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355) and biological products licensed under 351 of the Public Health Service Act (42 U.S.C. 262) that are drugs. 3
We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
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