FDA announces FY 2019 fee rates for PDUFA, GDUFA, and Outsourcing Facility Fees

Earlier this week, the FDA announced biosimilar user fees rates for fiscal year (FY) 2019.  We now have information on additional FY2019 user fee rates, which are effective on October 1, 2018, and will remain in effect through September 30, 2019:

1. Prescription Drug User Fee Rates for Fiscal Year 2019

The FDA is announcing the FY 2019 rates for prescription drug user fees. 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.

2. Generic Drug User Fee Rates for Fiscal Year 2019

The FDA is announcing FY 2019 rates for the Generic Drug User Fee Amendments of 2017 (GDUFA II) fees. The FD&C Act, as amended by the GDUFA II, authorizes the FDA 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.  

3. Outsourcing Facility Fee Rates for Fiscal Year 2019

The FDA is announcing the FY 2019 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the 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.