An FDA spokeswoman defended the agency's handling of the review, saying that "overall, this is the most transparent manner ever used for a new animal drug application."
一个FDA的发言人这样为FDA的立场辩护：“说到底，这已经是一个新的兽药申请审批中从没有过的透明度了。”
New opportunity and wide application career for the research of formulations of drug and pesticide are provided by nanotechnology.
纳米技术为医药和农药剂型的研究提供了新机遇，具有广阔的应用前景。
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。
With the research and application of the new ultrasound microbubble contrast agents, ultrasonic microbubbles can not only help to image, but they can also be used as genes or drug carriers.
随着新型超声微泡造影剂的研究和应用，超声微泡不仅能增强超声造影，而且也能作为运送基因或药物的载体。
As a new anti - virus, anti - tumor drug, antisense nucleic acid's application has been given more and more attention, but the research of antisense nucleic acid technology also faces some challenges.
反义核酸作为一种新的抗病毒、抗肿瘤药物，它的应用受到越来越多的重视，但反义核酸技术的研究也面临一些挑战。
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OT C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。
Verify product description; Submit data of clinical trials and new drug registry application.
负责审核和确认产品说明书，在规定时限内提交临床试验和新药注册申请；
Approval of a drug requires the submission and approval of a new drug application or an abbreviated new drug application.
药物的批准要求一个新药或者仿制药的递交和批准。
New combination therapies and their application to previously ineligible groups, including children and intravenous drug users, were a major thrust of the conference.
新的联合治疗，以及他们以前在不合格的人群，包括儿童与静脉药物滥用者中的应用，是此次协商会议的主要依据。
With the application of new chemotherapeutic agent and targeted drug, medical treatment for gastric carcinoma has made some progresses and clinical drug selection was more diversified than before.
随着近年来新型化疗和靶向药物的应用，胃癌的内科治疗水平不断提高，临床选择也日益多样化。
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。
The result indicates that, as a new type of drug-delivery system, nano-disperse systems have a wide prospect in its development and application.
结果表明，作为一种新型给药系统，纳米分散系具有广阔的开发与应用前景。
Along with the development and application of new drugs, the incidence of drug-induced erythroderma tends to increase, so does the number of sensitizing drugs.
随着药物的使用和新药的开发应用，药物过敏引起的红皮病呈上升趋势，致敏药也逐渐增多。
The appearance and application of new antiepileptic drug, brought hope to the children with epilepsy to entitle them more chances for selection.
新型抗癫痫药的问世和应用，给儿童癫痫患者的治疗带来了希望和更多的选择。
The mechanism of action, pharmacokinetics, clinical application, drug interactions, and adverse reactions of new atypical antipsychotics paliperidone, iloperidone, and asenapine were reviewed.
对新型非典型抗精神病药帕利哌酮、伊洛哌酮和阿塞那平的作用机制、药动学、临床应用、药物相互作用及不良反应等进行简要介绍。
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。
The Blood manufacturing community began implementation of Nucleic Acid Amplification Testing (NAAT) under the FDA's Investigational New Drug (IND) application process.
血液制造商开始根据FDA的研究性新药(IND)申请程序执行核酸检测(NAAT)。
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。
In charge of application of drug production permit and domestic and international registration, and GMP certification of new API.
负责药品生产许可证的申领工作，新品的国内和国际注册工作及GMP认证工作。
This invention provides a new camptothecin derivative with anti-tumor activity and structure as the right formula dissolving in water, its application, and its drug combinations.
本发明提供一类具有以右式结构式所示结构的新的具有抗肿瘤活性的能溶于水的喜树碱衍生物及其应用、以及包括该化合物的药物组合物。
In recent years the treatment of drug research and development is very active in a variety of new drugs, but from the clinical application of the survey, the overall efficiency was not high.
近年来对治疗药物的研究开发非常活跃，出现了多种新药，但是从临床应用情况的调查来看，总的显效率不高。
Conclusion: Scutellaria and active ingredients possess a wide prospect of clinical application, and a new drug hope for antiviral herbs.
结论：黄芩具有广阔的临床应用前景，有望开发成为安全有效的中药抗病毒新药。
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。
This process allows a company to file the sections of the New Drug Application (NDA) as they become available instead of filing all the sections at once.
这个过程允许公司提交的新药申请（NDA），因为它们变得可用，而不是提出在一旦所有的部分章节。
Investigational New Drug Application (IND) for the compound.
为化合物的研究中的新药物申请(IND)。
Based on the therapeutic characteristics of these drugs and the questions in new photosensitive drug application in China, in this review we indicated the key points of safety and effectiveness...
现结合有关光敏剂和光动力治疗的治疗学特点、当前国内光敏剂申报中存在的问题等，探讨光敏药物研发关键点，以期为国内该类药物安全有效性的综合评价提供参考。
Based on the therapeutic characteristics of these drugs and the questions in new photosensitive drug application in China, in this review we indicated the key points of safety and effectiveness...
现结合有关光敏剂和光动力治疗的治疗学特点、当前国内光敏剂申报中存在的问题等，探讨光敏药物研发关键点，以期为国内该类药物安全有效性的综合评价提供参考。
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