立卷审查相关表单是否要提交？
注册申报
2017-12-26 07:46 成龙     
举报
 评论 回答
2个回答

对于申报FDA的，有 ANDA checklist,如果申请人自己进行了审查，自己填写了审查表单，这个表单不建议在申报资料里提交。

Some applicants submit of a completed checklist with the submission. The DFR Reviewer does not review the applicant’s complete checklist during the filing review and may advise applicants, as appropriate, that submission of a completed checklist is not recommended.

详见 FDA MAPP 5200.14 Filing Review of Abbreviated New Drug Applications 201709

 

2017-12-26 10:48 Hang     
评论

image1、 问：立卷审查相关表单是否要提交？

答：立卷审查自查用表是为了帮助申请人提高申报资料质量，申请人应按照相应的要求在申报前进行自查。鼓励申请人将自查表放入申报资料中。http://www.cde.org.cn/news.do?method=viewInfoCommon&id=314235

 

2017-12-26 10:44 Xl     
评论