FDA Announces Fiscal Year 2016 Generic Drug Fees

Today the U.S. Food and Drug Administration (FDA) published the fiscal year 2016 generic drug user fees as required under the Generic Drug User Fee Amendments of 2012 (GDUFA) in the Federal Register. This announcement includes the rates for the abbreviated new drug application (ANDA), prior approval supplement to an approved ANDA (PAS), Type II active pharmaceutical ingredient drug master file (DMF), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees.

GDUFA authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference.

These fees are effective on October 1, 2015, and will remain in effect through September 30, 2016.