As required by the Generic Drug User Fee Amendments of 2012, FDA has announced the 2016 rates for the following user fees:
These fees are collected to ensure FDA has the needed funds to employ the staff needed to review drugs in a timely manner, thus getting drugs approved and to market in a more efficient time frame. The rates are amended annually and are effective each fiscal year, from October 1 to September 30.
The generic drug user fee rates for fiscal year 2016 are as follows:
Applications:
| Fee Category |
Fee Rates for FY 2016 |
| Abbreviated New Drug Application (ANDA) | $76, 030 |
| Prior Approval Supplement (PAS) to ANDA | $38,020 |
| Drug Master File (DMF) | $42,170 |
Facilities:
| Fee Category |
Fee Rates for FY 2016 |
| Active Pharmaceutical Ingredient (API) - Domestic | $40,867 |
| API – Foreign | $55,867 |
| Finished Dosage Form (FDF) – Domestic | $243,905 |
| FDF – Foreign | $258,905 |