On January 16, 2013, the Food and Drug Administration (FDA) announced the rate for the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA) authorizes FDA to assess and collect user fees for certain applications and supplements associated with human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on Type II API drug master files (DMF) to be made available for reference. GDUFA also directs FDA to establish each year the generic drug user fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the fiscal year. FDA January 16 announcement established the FY 2013 rate for API and FDF facility fees, which are due on March 4, 2013.
More information regarding the Generic Drug User Fee Amendments of 2012 is available here.