FDA仿制药的电荷（GDUFA）支付（中文和英文）.docVIP

以下内容原文FDA官网网址： HYPERLINK /ForIndustry/UserFees/GenericDrugUserFees/ucm322629.htm /ForIndustry/UserFees/GenericDrugUserFees/ucm322629.htm ? Generic Drug User Fee Cover Sheet and Payment Information 仿制药费用封面页和支付信息 The Generic Drug?User Fee Amendments of 2012 authorizes FDA to assess and collect user fees for human generic drug applications, certain application supplements, and related manufacturers. Form FDA 3794, also known as the Generic Drug User Fee Cover Sheet or GDUFA Cover Sheet, is designed to collect the minimum necessary information to determine the total applicable user fee required