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...法规要求、研究者责任、研究者声明等内容· Form FDA 3674 (PDF - 3MB): Certification of Compliance,合规性认证表格是FDA要求申请人在提交新药或医疗器械申请时填写的一份表格。它用于确认申请人的产品在制造和分销过程中符合适用的...
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...费表（FDA 3794 表） ★符合42 U.S.C. 282(j)(5)(B)证书（FDA 3674表） ★美国代理人授权书 ★真实副本证明（§ 314.94(d)(5)） ★仿制药实施法（禁令申明） ★临床研究者与申请者无经济利益申明（FDA 3455表） ★专利...
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...ng documents and information: ·Complete and signed Form FDA 356h and 3674 ·Cover letter for a summary of the submission, special requests, and application-specific references ·Agent appointment letter (as applicable) ·Assess whether FDA has been authorized to correspond with ...
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...ng documents and information: ·Complete and signed Form FDA 356h and 3674 ·Cover letter for a summary of the submission, special requests, and application-specific references ·Agent appointment letter (as applicable) ·Assess whether FDA has been authorized to correspond with ...
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...sions16·Form FDA 3794 – Generic Drug User Fee Cover Sheet17 ·Form 3674 – Certification of Compliance Under 42 U.S.C. § 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. § 282(j))1.2Contains a cover letter. A suggested cover letter template is included in this gu...