FDA官网推出eCTD汉化版讲座：

FDA官网推出eCTD汉化版讲座：
file:///C:\DOCUME~1\ADMINI~1\LOCALS~1\Temp\%W@GJ$ACOF(TYDYECOKVDYB.pnghttps://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm559631.htm

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• proval Process (Drugs)
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• CDER Small Business and Industry Assistance
  

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[size=0.875em]SBIA Resources in Chinese 中文信息

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Below are selected SBIA materials that have been translated into Chinese for reference purposes only.
以下是被选出并翻译成中文的SBIA资料，仅供参考。

• Electronic Submission Requirements for ANDAs: Are You Ready? [简化新药申请（ANDA）的电子提交要求：你准备好了吗?]- November 21, 2016  - 2016年11月]
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  登录/注册后可看大图
  
  Printable Slides
• Study Data Standards in eCTD: What You Need to Know about the New Technical Rejection Criteria [eCTD研究数据标准：你应该了解的关于新技术拒绝标准的内容] - October 12, 2016
  9 m3 N* |; b( _- T" cWebinar in Chinese
  
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  登录/注册后可看大图
  
  Printable Slides
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