CDER User Fee Rates for Fiscal Year 2020

FDA is announcing user fee rates for fiscal year 2020 for prescription drugs, generic drugs, biosimilars, and outsourcing facilities. See below federal register notices for more information. Prescription Drug User Fee Rates for Fiscal Year 2020 The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2020. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products, and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2020.  Learn More about Prescription Drug User Fee Rates for Fiscal Year 2020

Generic Drug User Fee Rates for Fiscal Year 2020 The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2020 rates for GDUFA II fees. Learn More about Generic Drug User Fee Rates for Fiscal Year 2020 Biosimilar User Fee Rates for Fiscal Year 2020 The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2020. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. Learn more about Biosimilar User Fee Rates for Fiscal Year 2020 Outsourcing Facility Fee Rates for Fiscal Year 2020 The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2020 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for each re-inspection of an outsourcing facility. This document establishes the FY 2020 rates for the small business establishment fee ($5,599), the non-small business establishment fee ($18,288), and the re-inspection fee ($16,798) for outsourcing facilities; provides information on how the fees for FY 2020 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective October 1, 2019, and will remain in effect through September 30, 2020. Learn More about Outsourcing Facility Fee Rates for Fiscal Year 2020