Generic Drug Fees for Finished Dosage Forms and Active Pharmaceutical Ingredient Facilities Announced - GDUFA FY2013 Summary
<On January 17, FDA published in the Federal Register the finished dosage form ("FDF") and active pharmaceutical ingredient ("API") facility fees for fiscal year 2013 ("FY2013") (October 1, 2012 to September 30, 2013). FDA's most recent publication rounds out the list of new user fees associated with generic drugs filed as abbreviated new drug applications ("ANDAs"), which were authorized by the Generic Drug User Fee Amendments of 2012 ("GDUFA") and enacted by the Food and Drug Administration Safety and Innovation Act of 2012.
GDUFA authorizes FDA to assess and collect fees for ANDAs and certain supplements associated with human generic drug products, ANDAs in the backlog as of October 1, 2012, finished dosage form ("FDF") and active pharmaceutical ingredient ("API") facilities, and on Type II drug master files ("DMF") to be made available to reference. FDA has been staggering its publication of these rates for FY2013 with the FDF and API facility fees as being the latest in the series.
To summarize these fees for FY2013:
(1) ANDA and Prior Approval Supplement ("PAS") fees were published in the Federal Register on October 25, 2012 as $51,520 for an ANDA and $25,760 for a PAS. If an ANDA is refused to file and the refusal is not related to a failure to pay fees, the applicant will receive 75% of this fee amount. If an ANDA fails to pay fees within 20 calendar days of submission, the application is deemed incomplete and will be "received" only after payment in full is received. User fees are required for all PASs, including labeling and microbiology that require prior approval under FDA regulations.