FDA新药评审——批准前检查

潇湘子 · 发表于 2013-3-3 09:32:40

欢迎您注册蒲公英

您需要登录才可以下载或查看，没有帐号？立即注册

x

CHAPTER 46- NEW DRUG EVALUATION——PRE-APPROVAL INSPECTIONS

TABLE OF CONTENTS
PART I - BACKGROUND1 ...........................................................................................................
PART II – IMPLEMENTATION2 ................................................................................................
2.1 Scope2 ........................................................................................................................
2.2 Strategy3 ....................................................................................................................
2.3 Program Management Instructions.5 .........................................................................
2.4 Importance of Review Independence8 .......................................................................
2.5 Knowledge Transfer Program.8 .................................................................................
PART III - INSPECTIONAL.9 ......................................................................................................
3.1 Inspection Scheduling and Preparation9 ....................................................................
3.2 Inspection Team10 .....................................................................................................
3.3 Inspection/Audit Strategy11 ......................................................................................
3.4 Inspection/Audit Coverage, Objectives, and Techniques......................................11
3.5 Inspection Reporting22 ..............................................................................................
3.6 Sample Collection or Sample Submission Requests25 .............................................
PART IV - ANALYTICAL27 .........................................................................................................
PART V - REGULATORY/ADMINISTRATIVE STRATEGY28 .............................................
PART VI - REFERENCES, ATTACHMENTS, AND PROGRAM CONTACTS30 ................
6.1 References30 ..............................................................................................................
6.2 Attachments31 ...........................................................................................................
6.3 Contacts32 .................................................................................................................
6.4 Acronyms33 ...............................................................................................................
PART VII - CENTER RESPONSIBILITIES.34

zdlxcb · 发表于 2013-3-3 10:07:47

谢谢分享啊

jjb2005 · 发表于 2013-3-3 10:10:04

收藏先，谢谢分享！

liuqygood2005 · 发表于 2013-3-3 10:10:35

学习下，多谢

小米0 · 发表于 2013-3-3 10:13:20

下载学习一下，谢谢楼主分享~~

Anne · 发表于 2013-3-3 12:09:54

潇湘子又发威了，呵呵支持

youngzhou · 发表于 2013-3-3 12:42:15

多谢楼主分享。

hldmfw · 发表于 2013-4-29 07:00:08

谢谢分享！

FDA新药评审——批准前检查

欢迎您注册蒲公英

相关帖子

点评

浏览过的版块