FDA Cytomegalovirus in Transplantation Developing Drugs to Treat or Prevent Disease
标准简介
Cytomegalovirus in Transplantation Developing Drugs to Treat or Prevent Disease[附网盘链接]是FDA于不久前发布的FDA标准，适用于U.S。标准截图
![Cytomegalovirus in Transplantation Developing Drugs to Treat or Prevent Disease[附网盘链接]](/img/20210914103709g2oxh.jpg)
标准文档说明
标准文档类型为Cytomegalovirus in Transplantation Developing Drugs to Treat or Prevent Disease[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
Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease 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 staff 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 to treat or prevent cytomegalovirus (CMV) disease in patients who have undergone solid organ 2
transplantation (SOT) or hematopoietic stem cell transplantation (HSCT). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for the development of drugs and therapeutic biological products to support an indication for treating or preventing CMV disease in post-transplant populations. This guidance is intended to facilitate continued discussions among the Division of Antiviral Products (DAVP), pharmaceutical sponsors, the academic 3
community, and the public. This guidance does not address drug development for treating or preventing congenital CMV infection or CMV infection in patients other than those undergoing SOT or HSCT. This guidance also discusses the use of CMV viremia, measured as DNAemia (CMV deoxyribonucleic acid (DNA) in blood determined by polymerase chain reaction (PCR)), as a validated surrogate endpoint in clinical trials. 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 Antiviral Products in the Center for Drug 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 therapeutic biological products unless otherwise specified. 3
In addition to consulting guidances, sponsors are encouraged to contact the DAVP to discuss specific issues that arise during the development of anti-CMV drugs.
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