FDA Sets GDUFA Fees for FY 2018

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-29-2017 15:54


The US Food and Drug Administration (FDA) has set fiscal year (FY) 2018 rates for the Generic Drug User Fee Amendments (GDUFA) fees, which are fees for the generic drug industry that supplement costs from the FDA for reviewing applications and inspecting facilities.

The Federal Food, Drug, and Cosmetic Act, as amended by the GDUFA, 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.

Some user fee prices have been raised. For FY ‘18, the generic drug fee rates are: ANDA ($171,823) up from $70,480; DMF ($47,829) up from $51,140; domestic API facility ($45,367) up from $44,234; and foreign API facility ($60,367) up from $59,234.

Meanwhile, fees that have dropped in price include: domestic FDF facility ($211,087), down from $258,646 and foreign FDF facility ($226,087), down from $273,646.

Other fees include: domestic CMO facility ($70,362), foreign CMO facility ($85,362), large-size operation generic-drug applicant program ($1,590,792), medium-size operation generic-drug applicant program ($636,317), and small-business generic-drug applicant program ($159,079).

These fees are effective on October 1, 2017, and will remain in effect through September 30, 2018.

Source: FDA



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