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

- e5 Q* F# U) A5 Q% w9 c( Q
- ^* x4 D: U% s- t

• proval Process (Drugs)
         
• CDER Small Business and Industry Assistance
  , X% Q( o& u) p2 M  X2 e

* ]1 R, L2 J0 k! J9 J( b# k[size=0.875em]SBIA Resources in Chinese 中文信息

• [size=0.7em][size=1.2em]SHARE
• [size=0.7em][size=1.2em]TWEET
• [size=0.7em][size=1.2em]LINKEDIN
• [size=0.7em][size=1.2em]PIN IT
• [size=0.7em][size=1.2em]EMAIL
• [size=0.7em][url=][size=1.2em]PRINT[/url]
  

# c+ }5 m( y0 Z7 O$ [

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]
  Webinar in Chinese
  
                                 
  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
  Webinar in Chinese
  
                                 
  登录/注册后可看大图
  
  ) {; [0 b0 |' f3 B2 p# zPrintable Slides
  

- g( n2 a/ D  \0 n' a4 G
, t; A) B/ P! u2 U# i2 [5 t- e
! E; q8 v/ k9 N+ I: b
$ |% J4 K/ `0 [, C4 K8 l! V

谢谢分享！！！！！！！！！！！！！！！！！