New Drug Application

Following the withdrawal , any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA .

在此次撤市之后，麦罗塔将来在美国的任何一种使用都将需要向FDA提交一项研究性新药申请。

UNAPPROVED : The article appears to be a new drug without an approved new drug application .

新药未经批准：此产品是新药，没有新药申请。

Investigational New Drug Application ( IND ) for the compound .

为化合物的研究中的新药物申请（IND）。

Research in Profile of Chemical Investigational New Drug Application in China

创新性化学药品在中国的申报状况研究

American Abbreviate New Drug Application Procedure and Juridical Penalty

美国简明药品申请程序及相关法律责任

AIM : To introduce the concept of bridging study and its strategies in clinical trials for new drug application .

目的：介绍新药临床试验中桥接试验的概念和实施策略。

Drug registration is classified into new drug application , supplementary application , license renew application , and import drug application .

药品注册分为新药注册申请、补充申请、药品再注册申请和进口药品申请。

Interpretion of FDA guidance on submission of summary bioequivalence data for abbreviated new drug application

FDA仿制药申请生物等效性数据资料提交指导原则介绍

This platform is composed by GRP experiment management system , GLP new drug application system and drug discovery standard workflow management system .

该平台由GRP实验管理系统、GLP新药申报系统和新药研发标准化流程管理系统组成。

But the new drug application for listing does not only have cumbersome procedure and demands for huge funds , but also takes the high risk .

但新药的上市申请不仅程序繁琐、资金需求巨大，而且资金一旦投入即成为沉没成本。

Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application .

如果制药公司希望标记OTC但没有达到专著要求的，均可以提交新药上市的申请和获得注册新药的许可。

Using the comparative analysis , logical antithesis , illustration and literature retrieval method , also doing a lot of tracking about the Internet News Information to compare the difficulties and difference between the two country in new drug application .

运用比较分析法、例证法和文献检索法，并做了大量的Internet动态信息跟踪查询。

On May 25 , 2005 , a New Drug Application ( NDA ) of depsides salts from Salvia miltiorrhiza and its preparation for the treatment of coronary artery disease had received official approval from State Food and Drug Administration ( SFDA ) .

2005年5月25日，经国家食品药品监督管理局（SFDA）批准，丹参多酚酸盐及其注射用丹参多酚酸盐的新药注册申请获得了新药证书和生产批文。