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:
FY 2017 Fee Rates
Abbreviated New Drug Application (ANDA)
Prior Approval Supplement (PAS) to an ANDA
Drug Master File (DMF)
Active Pharmaceutical Ingredient (API) – Domestic
API – Foreign
Finished Dosage Form (FDF) – Domestic
FDF – Foreign
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