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


6 g" R. z2 K2 V- V3 Y$ \

• proval Process (Drugs)
  ! B' u2 g. T$ V$ o       
• CDER Small Business and Industry Assistance
  

/ z) i3 {3 M, u% V9 ]+ u7 \
/ k: E& b- m/ J" m. A' R% ^[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]
  ; t  T" J8 }" k( i* `' b

7 A, V5 g- q& N4 R; C5 m' h4 |7 [
- G4 T) _9 y$ g; a2 r

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]
  % i0 n* c! i3 m. j2 V5 M9 ]" mWebinar 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
  
  Printable Slides
  

0 Z; W& f' s2 o. ~2 \4 X& ?# _

1 t; J! F/ v1 w

谢谢分享！！！！！！！！！！！！！！！！！