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                CDER Small Business & Industry Assistance (SBIA)

CDER Small Business & Industry Assistance (SBIA)

                        About CDER Small Business and Industry Assistance (SBIA)
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          CDER Small Business & Industry Assistance (SBIA)
          SBIA Resources in Chinese 中文信息CDER Small Business & Industry Assistance (SBIA) SBIA Resources in Chinese 中文信息
  
  	
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    PrintBelow 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。

An Overview of FDA’s Guidance - Drug Supply Chain Security Act Implementation---Identification of Suspect Product and Notification [FDA指南概述:《药品供应链安全法》的实施---可疑产品的识别与报告 December 2016 – 2016年12月]Webinar in Chinese 中文版Printable Slides 幻灯片
	Establishment Registration and Listing for Human Drugs---Highlighting Recent Amendments [人用药品机构/企业注册和产品列表/登记---侧重于近期修订内容 September 2016 – 2016年9月]Webinar in Chinese   中文版 Printable Slides 幻灯片
	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 中文版Printable Slides 幻灯片
	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  - 2016年10月]Webinar in Chinese 中文版Printable Slides 幻灯片
	Generic Drug User Fee Amendments II (GDUFA II) [仿制药用户费用修正案II (GDUFA II) April 4, 2017 – 2017年4月]Webinar in Chinese   中文版Printable Slides 幻灯片
	Generic Drug Labeling: Strategies for Providing High-quality Submissions [仿制药标签:提交高质量申请的策略 April 5, 2017 – 2017年4月]Webinar in Chinese   中文版Printable Slides 幻灯片

                                                                                  Content current as of:
      04/24/2018CDER Small Business & Industry Assistance (SBIA)

          
                        About CDER Small Business and Industry Assistance (SBIA)
          CDER SBIA Learn
          Search for Regulatory References | Drugs
          CDER SBIA YouTube Learning Library
 
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