FDA Lowers ANDA Fee Rates for 2017

Jul 27, 2016

Regulatory Affairs Professional Society

The FDA will lower fees in 2017 for generic drug manufacturers submitting abbreviated new drug applications (ANDAs) and prior approval supplements (PAS). All other rates, including those for drug master files (DMF) and facility fees, will be higher compared to 2016.

According to RAPS, for FY 2017, the generic drug fee rates are: ANDA ($70,480, down from $76,030 in 2016), PAS ($35,240, down from $38,020 in 2016), DMF ($51,140, up from $42,170 in 2016), domestic active pharmaceutical ingredient (API) facility ($44,234, up from $40,867 in 2016), foreign API facility ($59,234, up from $55,867 in 2016), domestic finished dose formulation (FDF) facility ($258,646, up from $243,905), and foreign FDF facility ($273,646, up from $258,905 in 2016).

The new fees are effective Oct. 1, 2016, and will continue through Sept. 30, 2017.

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