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kkhui

[交流] 【求助】FDA上的approval type分别什么意思 已有2人参与

请问高手FDA网站上新通过的药物有各种APPROVAL TYPE .如tentative approval ,supplement,approval .分别代表什么意思?
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ine

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For those that cannot be marketed in the United States due to existing patent protection, a so-called "tentative" approval is granted. Tentative approval means that existing patents or exclusivity prevent the product from being sold in the United States, but that the product meets all of the scientific and quality standards for marketing in the U.S.
幸福原本不多,珍惜累积渐长。
3楼2010-09-03 09:35:52
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龙文

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karl2100(金币+1):谢谢回复! 2010-08-29 23:54:29
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Originally posted by kkhui at 2010-08-29 19:58:44:
请问高手FDA网站上新通过的药物有各种APPROVAL TYPE .如tentative approval ,supplement,approval .分别代表什么意思?

approval type 是认证类别,好像是临时认证和增补认证吧
2楼2010-08-29 20:45:52
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ine

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supplement类似中国的补充申请,而approval则是full approval,相当于中国的正常注册申请批准。
幸福原本不多,珍惜累积渐长。
4楼2010-09-03 09:37:23
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