FDA meeting - RegulatoryAffairs版 - 未名存档

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RegulatoryAffairs版 - FDA meeting

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● Meetings with FDA
● 友情鸣谢新版申请中大力支持的 id. 并赠送小礼品。
● FDA forms
● FDA approved Eli Lilly's Trulicity to treat T2D
● FDA guidance for industry
● FDA Announces Major Regulatory Changes, With Specialization a Key Focus
● FDA Announces Major Agency Reorganization, With Focus on Drug Quality
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● prepare an FDA pre-approval inspection (PAI)
● Use of International Standard ISO- 10993 - FDA's current thoughts on biocompatibility

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● Use of International Standard ISO- 10993 - FDA's current thoughts on biocompatibility
● FDA's Latest Biosimilars Guidance: How to Show Biosimilarity Using Pharmacological Testing
● 怎么找手机医用app申请510K的例子？
● DMF - drug master file
● Regulatory body TUV
● 分享个FDA 101的课程吧，另外打算考2015 fall的RAC 求study group
● RAC经验咨询
● 问一个中国药品在美国注册的问题
● Postdoc转RA，几种方案求建议
● FDA Consultant NEEDED

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话题: fda话题: meeting