FDA Chronic Hepatitis B Virus Infection Developing Drugs for Treatment
标准简介
Chronic Hepatitis B Virus Infection Developing Drugs for Treatment[附网盘链接]是于不久之前发布的FDA标准，适用于U.S。标准截图
![Chronic Hepatitis B Virus Infection Developing Drugs for Treatment[附网盘链接]](/img/20210914103615exdgp.jpg)
标准文档说明
标准文档类型为Chronic Hepatitis B Virus Infection 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
Draft — Not for Implementation 1 Chronic Hepatitis B Virus Infection: 2 Developing Drugs for Treatment 1 3 Guidance for Industry 4 5 6 7 8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency blish any rights ) on thi s topic. It does not estafor any person and is not 10 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 11 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 12 for this guidance as listed on the title page. 13 14 15 16 17 I. INTRODUCTION 18 19 The purpose of this guidance is to assist sponsors in the clinical development of drugs and 20 biologics for the treatmhronic hepatitis B virus (HBV) ent of c infection from the initial 21 investigational new drug applic application (NDA)/biologics ation (IND) through the new drug
2
22 license application (BLA) and postmarketing phases. This draft guidance is intended to serve as 23 a focus for continued discussions amal Products (DAVP), ong the Division of Antivir
3
24 pharmaceutical sponsors, the acad. Sponsors are also emic community, and the public
25 encouraged to communicate with DAVP through the pre-IND consultation program to obtain 26 advice in the development of drased on mugs with unique considerations b echanism of action, 4 27 novel treatment approaches, or t he use of novel biomarkers.
28 29 This guidance does not address dev-derived products, as these are elopment of vaccines or blood
30 regulated by the Center for Biologics Evaluation and Research. This guidance also does not 31 contain discussion of the general issues of statistical analysis or clinical trial design. Those 1
This guid apnrece pa byhas red the bee o ADn f intviisvroiiordun alcts in th P e Cen anter for Drud g Evaluation Research at th Ade Foodministratio and Drug n. 2
For the purposes of th drugsi is gunclidude ance, all rboth therahumean d bpeutfieorleruogi inces to c gs acal nd product unless s other wise specified. 3
In addition to con gsuuilting des, spoanc nsors are encourcuss saged tpo contact the Decific issues tAVhat P to dis
arise during the devt oelopf chrmenonic HBV drugs. 4
See t DAVhP Pree -IN LetD ter of weInstb pager htuctt/w at pwwis:o.fd/n a.gov/Drugs/DevelopmentApprovalPro-
cess/HowDrugsareDevelopedandApptigroveatiod/ApnpraloNvewDrugalApplINDAppicatlicatioions/Inven/Ovs er-
view/ucm077776.htm. 1
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