The US Food and Drug Administration (FDA) has announced the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs),generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2016. The notice of the fees were published August 3, 2015 in the Federal Register.
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), authorizes the FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012 (only applicable to FY 2013), on FDF and API facilities, and on Type II active pharmaceutical ingredient DMFs to be made available for reference. The Federal Register notice establishes the fee rates for FY 2016.
For FY 2016, the generic drug fee rates are: ANDA ($76,030), PAS ($38,020), DMF ($42,170), domestic API facility ($40,867), foreign API facility ($55,867), domestic FDF facility ($243,905), and foreign FDF facility ($258,905). These fees are effective on October 1, 2015, and will remain in effect through September 30, 2016.
Fees for ANDA, PAS, and DMF will increase in FY 2016 over the corresponding fees in FY 2015 due to a drop in the number of submissions in each of those three categories over the course of FY 2015. The fees for all types of facilities will decrease in FY 2016 over the corresponding fees in FY 2015 due to an increase in the number of facilities that self-identified for FY 2016.