美国仿制药用户收费法案(GDUFA).pdfVIP

4160-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0007] Generic Drug User Fee--Abbreviated New Drug Application, Prior Approval Supplement, and Drug Master File Fee Rates for Fiscal Year 2013 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the rate for the abbreviated new drug application (ANDA), prior approval supplement (PAS), and drug master file (DMF) fees related to the Generic Drug User Fee Program for fiscal year (FY) 2013. The Federal Food, Drug, and