FDA 的Complete Response Letter 是什么意思
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解决时间 2021-01-25 14:36
- 提问者网友：嘚啵嘚啵
- 2021-01-24 20:30
FDA 的Complete Response Letter 是什么意思
最佳答案
- 五星知识达人网友：独行浪子会拥风
- 2021-01-24 22:02
请问贵司是在申请新药么？Complete Response Letter 指您递交的新药申请资料FDA官员已经审核，但是新药仍然待批准使用。以下参考： The final rule discontinues FDA’s use of approvable letters and not
approvable letters when taking action on marketing applications.
Instead, we will send applicants a complete response letter to indicate
that the review cycle for an application is complete and that the
application is not ready for approval.
approvable letters when taking action on marketing applications.
Instead, we will send applicants a complete response letter to indicate
that the review cycle for an application is complete and that the
application is not ready for approval.
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