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prescription drug user fee act 添加释义

网络释义英英释义

  处方药使用者费用法

处方药使用者费用法》(PRESCRIPTION DRUG USER FEE ACT),国家食品药品要求和生物制品制造商为产品申请和补充以及其它服务,支付费用。

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  处方药使用者收费法案

自1992年《处方药使用者收费法案》(Prescription Drug User Fee Act)公布实施后,新药从临床研发到通过美国FDA审批这一平均周期已经显著缩短。

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  处方药收费法案

这些问题也因此成为美国制定处方药收费法案(Prescription Drug User Fee Act,PDUFA)中最富有争议性的话题。

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  处方药用户收费法

1992年,它推行了《处方药用户收费法》( Prescription Drug User Fee Act),要求制药公司向FDA支付用户费用。这项规定只在加速批准药物时才生效。

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Prescription Drug User Fee Act

  • abstract: The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities.

以上来源于: WordNet

双语例句权威例句

  • In its draft, "Prescription Drug User Fee Act (PDUFA) iv Drug Safety Five-Year Plan," the agency says it will focus on hiring the staff through fiscal year 2009.

    计划草案为处方药消费者付费法案(PDUFA) IV药品安全五年计划”,据相关机构介绍方案将会2009年的年度财政中获取经费用于雇佣相关人员

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  • The FDA has accepted the Company's NDA for filing and has set a Prescription Drug User Fee act (PDUFA) target action date for the Company's NDA of January 23, 2008.

    食品与药品管理局已经接受公司新药申请文件归档,而且还组织处方药物使用权行动,活动目标是将公司新药注册日期定2008年一月二十三日。

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