FDA Chronic Hepatitis D Virus Infection Developing Drugs for Treatment Guidance for Industry
标准简介
Chronic Hepatitis D Virus Infection Developing Drugs for Treatment Guidance for Industry[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于United States。标准截图
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标准文档类型为Chronic Hepatitis D Virus Infection 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
Draft — Not for Implementation 1 Chronic Hepatitis D Virus Infection: 2 Developing Drugs for Treatment 1
3 Guidance for Industry 4 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 9 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 10 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 11 for this guidance as listed on the title page. 12 13 14 15 I. INTRODUCTION 16 17 The purpose of this guidance is to assist sponsors in the clinical development of drugs for the 2
18 treatment of chronic hepatitis D virus (HDV) infection. Specifically, this guidance addresses the 19 Food and Drug Administration’s (FDA’s) current recommendations regarding the overall 20 development program and clinical trial designs for the development of drugs and biologics to 21 support an indication for the treatment of chronic HDV infection. 22 23 FDA encourages sponsors to communicate with the Division of Antiviral Products (DAVP) 24 through the pre-investigational new drug application (pre-IND) consultation program to discuss 25 the development of drugs with unique considerations based on mechanism of action, novel 3
26 treatment approaches, or the use of novel biomarkers. This draft guidance is intended to serve as 27 a focus for continued discussions among DAVP, pharmaceutical sponsors, the academic 4
28 community, and the public. 29 30 This guidance focuses on considerations that are specific to HDV drug development. General 31 topics in early phase drug development, statistical analysis, and clinical trial design are addressed 32 in the International Conference on Harmonisation (ICH) guidances for industry E9 Statistical 33 Principles for Clinical Trials (September 1998) and E10 Choice of Control Group and Related 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, the term drug includes both human drugs and therapeutic biological products unless otherwise specified. 3
See the FDA’s Getting Started with the Division of Antiviral Products Pre-IND Process web page at https://www.fda.gov/drugs/pre-ind-consultation-program/getting-started-division-antiviral-products-pre-ind-process. 4
In addition to consulting FDA guidances, sponsors are encouraged to contact DAVP to discuss specific issues that arise during the development of drugs for the treatment of HDV infection.
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