Prescription Drug User Fee Amendments 2018-2019

Prescription Drug User FeeAmendments (http://go.fda.gov/subscriptionmanagement) Sign up to receive email updates about the PrescriptionDrug User Fee Act (PDUFA) (http://go.fda.gov/subscriptionmanagement)Latest News:The FY 2019 Program Fee invoices were emailed Wednesday, August 15, 2018. Full payment of theinvoice is due October 1, 2018. If you do not receive your invoice by August 17, 2018, please contactPDUFA User Fee staff at 301-796-7900 or at CDERCollections@fda.hhs.gov(mailto:CDERCollections@fda.hhs.gov). (posted 08/15/2018)The Prescription Drug User Fees for Fiscal Year 2019 have been published. Please see the table belowfor the 2019 and 2018 rates.FY 2019 user fee rates:User Fee TypeApplication Fee - Clinical Data RequiredApplication Fee - No Clinical Data RequiredProgram Fee2019 $ 2,588,478 $ 1,294,239 $ 309,9152018 $ 2,421,495 $ 1,210,748 $ 304,162Background and LegislationThe Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA tocollect fees from companies that produce certain human drug and biological products. Since the passageof PDUFA, user fees have played an important role in expediting the drug approval process.PDUFA (ssLINK/UCM147983) must be reauthorized every five years, and was renewed in 1997 (PDUFA II(/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm145396.htm)), 2002 (PDUFA III(/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm118814.htm)), 2007 (PDUFA IV(/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm145390.htm)), and 2012 (PDUFA V(/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm272170.htm)) and 2017 (PDUFA VI(/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm446608.htm)). On August 18, 2017, thePresident signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includesthe reauthorization of PDUFA through September 2022. PDUFA VI(/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm446608.htm) will provide for the continued timelyreview of new drug and biologic license applications.Regulations and Federal Register Documentshttps://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm1/22018/8/17Prescription Drug User Fee AmendmentsRegulations and Federal Register DocumentsApplication FeesProgram FeesPayment Information and Cover SheetWaivers, Reductions, and RefundsReauthorization ActivitiesRelated InfoContact Us More in Prescription Drug User Fee Act (PDUFA)(/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm)https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm2/2