Today the U.S. Food and Drug Administration (FDA) published the fiscal year 2014 generic drug user fees as required under the Generic Drug User Fee Amendments of 2012 (GDUFA) in the Federal Register. FDA is aware that industry is adjusting to the new requirements and fees, and FDA minimized the increase in fees as much as possible.
As specified in the statute, the fiscal year 2014 fees include an increase over the 2013 fees. In the first year of the program (2013), the total revenue included a one-time fee for applications pending as of October 1, 2012. With this one-time fee removed from the calculation, the remaining fees make up the total revenue, which resulted in the increase. Additional factors, including the number of facilities that self-identify under GDUFA, are also used in calculating the facility fee.
Federal Register: Generic Drug User Fee—Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee
- Frequently Asked Questions: Facility Fees
- Frequently Asked Questions: Drug Master File Fee
- Frequently Asked Questions: Abbreviated New Drug Application (ANDA) and Prior Approval Supplement (PAS) Fees