The FDA has announced the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facility user fee rates for fiscal year 2013. The API facility fee is owed by each person that owns a facility which produces, or which is pending review to produce, one or more APIs identified, or intended to be identified, in at least one generic drug submission that is pending or approved or in a Type II API master file referenced in such generic drug submission. The API facility fee for 2013 for domestic facilities is $26,458, while the API facility fee for foreign facilities is $41,458. The FDF facility fee is owed by each person that owns a facility which is identified or is intended to be identified, in at least one generic drug submission that is pending or approved, to produce one or more finished dosage forms of the human generic drug. The FDF facility fee for 2013 for domestic facilities is $175,389, and the FDF facility fee for foreign facilities is $190,389. Both API and FDF fees are due on March 4, 2013. FDA is authorized to collect these fees, among others, under the Generic Drug User Fee Amendments of 2012.
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FDA announces 2013 generic drug active pharmaceutical ingredient and finished dosage form facility user fee rates
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