prepare an FDA pre-approval inspection (PAI) - RegulatoryAffairs版 - 未名存档

本页内容为未名空间相应帖子的节选和存档，一周内的贴子最多显示50字，超过一周显示500字访问原贴

RegulatoryAffairs版 - prepare an FDA pre-approval inspection (PAI)

相关主题
● Tips for preparing a successful eCTD	● 如何全面提高医药法规注册人员的综合素质
● 友情鸣谢新版申请中大力支持的 id. 并赠送小礼品。	● Use of International Standard ISO- 10993 - FDA's current thoughts on biocompatibility
● FDA forms	● Meetings with FDA
● FDA approved Eli Lilly's Trulicity to treat T2D	● FDA's Latest Biosimilars Guidance: How to Show Biosimilarity Using Pharmacological Testing
● FDA guidance for industry	● 怎么找手机医用app申请510K的例子？
● FDA meeting	● DMF - drug master file
● FDA Announces Major Regulatory Changes, With Specialization a Key Focus	● Regulatory body TUV
● FDA Announces Major Agency Reorganization, With Focus on Drug Quality	● 分享个FDA 101的课程吧，另外打算考2015 fall的RAC 求study group

相关话题的讨论汇总
话题: fda话题: pai话题: prepare话题: inspection话题: approval

进入RegulatoryAffairs版参与讨论

1

(共1页)

s**********8 发帖数: 25265	1 http://artwork.net/ks/asq711/pdf/preparing4fda_july_07.pdf
D****2 发帖数: 2656	2 Are you a FDA consultant?
s**********8 发帖数: 25265	3 ye I am :D 【在 D****2 的大作中提到】 : Are you a FDA consultant?
D****2 发帖数: 2656	4 Cool. Like helping your clients to submit 510K stuffs? I used to work for a med equip company who used to use service in calif, but then they switched to one in Shanghai. 【在 s**********8 的大作中提到】 : ye I am :D
s**********8 发帖数: 25265	5 cool where u based now? a 【在 D****2 的大作中提到】 : Cool. Like helping your clients to submit 510K stuffs? I used to work for a : med equip company who used to use service in calif, but then they switched : to one in Shanghai.
D****2 发帖数: 2656	6 I'm in Calif, but I no longer stay in the same field. = ) 【在 s**********8 的大作中提到】 : cool where u based now? : : a
s**********8 发帖数: 25265	7 which field now? 【在 D****2 的大作中提到】 : I'm in Calif, but I no longer stay in the same field. = )

1

(共1页)

进入RegulatoryAffairs版参与讨论

相关主题
● 分享个FDA 101的课程吧，另外打算考2015 fall的RAC 求study group	● FDA guidance for industry
● RAC经验咨询	● FDA meeting
● 问一个中国药品在美国注册的问题	● FDA Announces Major Regulatory Changes, With Specialization a Key Focus
● Postdoc转RA，几种方案求建议	● FDA Announces Major Agency Reorganization, With Focus on Drug Quality
● Tips for preparing a successful eCTD	● 如何全面提高医药法规注册人员的综合素质
● 友情鸣谢新版申请中大力支持的 id. 并赠送小礼品。	● Use of International Standard ISO- 10993 - FDA's current thoughts on biocompatibility
● FDA forms	● Meetings with FDA
● FDA approved Eli Lilly's Trulicity to treat T2D	● FDA's Latest Biosimilars Guidance: How to Show Biosimilarity Using Pharmacological Testing

相关话题的讨论汇总
话题: fda话题: pai话题: prepare话题: inspection话题: approval

未名新帖统计// 7月16日

#	版面	帖数(主题数)
-	全站	4871 (796)
1	Military	3777 (569)
2	Stock	341 (51)
3	Joke	117 (17)
4	History	116 (3)
5	Automobile	100 (9)
6	USANews	55 (9)
7	Midlife	45 (1)
8	Headline	41 (41)
9	Dreamer	33 (13)
10	FleaMarket	32 (20)
11	Living	30 (7)

* 这里只显示发帖超过25的版面，努力灌水吧:-)