FDA Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer Developing Drugs and Biologics for Treatment
标准简介
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer Developing Drugs and Biologics for Treatment[附网盘链接]由FDA于之前发布，适用于美国。标准截图
![Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer Developing Drugs and Biologics for Treatment[附网盘链接]](/img/20210914103559re5r0.jpg)
标准文档说明
标准文档类型为Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer Developing Drugs and Biologics 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
BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics 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 development of drugs, including biologics, for the treatment of patients who have bacillus Calmette-Guérin (BCG)-unresponsive 2
nonmuscle invasive bladder cancer (NMIBC). This guidance is intended for pharmaceutical sponsors, the academic community, and the public and provides a framework, based on current Food and Drug Administration (FDA) thinking, to facilitate the development of drugs to treat 3
this patient population. This guidance discusses pathological diagnosis and staging, risk stratification, and trial design, including assessment of appropriate clinical endpoints. These issues were discussed at the FDA/American Urological Association Bladder Cancer Workshop held on May 6, 2013, and in published literature (Jarow et al. 2014; Jarow et al. 2015). Many of the general principles elucidated in this guidance also apply to development of drugs for other forms of NMIBC. Nevertheless, the specific recommendations for trial design and endpoints contained herein may not necessarily apply, and sponsors should discuss with the FDA development plans for drugs intended to treat other forms of NMIBC or for muscle invasive, locally advanced, or metastatic bladder cancer. 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 1
This guidance has been prepared by the Division of Oncology Products 1 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 the purposes of this guidance, all references to drugs include both human drugs and biological products unless otherwise specified. 3
In addition to consulting guidances, sponsors are encouraged to contact the division to discuss specific issues that arise during the development of drugs for the treatment of BCG-unresponsive NMIBC.
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