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FDA Generic Drug User Fee Rates: Fiscal Year 2017

August 4, 2016

FDA has announced its 2017 user fee rates related to the Generic Drug User Fee Program, which includes:

  • Abbreviated new drug applications (ANDAs)
  • Prior approval supplements (PASs) to an approved ANDA
  • Drug master files (DMFs)
  • Generic drug active pharmaceutical ingredient (API) facilities
  • Finished dosage form (FDF) facilities

These fees are effective from October 1, 2016 through September 30, 2017.  In its notice, FDA states that it expects to see an increase in the number of ANDA and PAS submissions that are received in 2017.  As such, the 2017 fees for these types of submissions have decreased compared to the Agency’s 2016 fees.  On the reverse side of that, FDA notes that the fees for DMF submissions have increased for 2017 compared to 2016, as it expects the number of these submissions to decrease next year.  Additionally, the fees associated with all types of facilities will also increase in FY 2017.  This is said to be due to a decrease in the number of facilities that have self-identified for fiscal year 2017.

FDA’s generic drug user fee rates for fiscal year 2017 are as follows:

Fee Category

 FY 2017 Fee Rates
Applications:
   Abbreviated New Drug Application (ANDA) $70,480
   Prior Approval Supplement (PAS) to an ANDA $35,240
Drug Master File (DMF) $51, 140
Facilities:
   Active Pharmaceutical Ingredient (API) – Domestic $44,234
   API – Foreign $59,234
   Finished Dosage Form (FDF) – Domestic $258,646
   FDF – Foreign $273,646

 

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