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August 7, 2015 FDA News

FDA Generic Drug User Fee Rates: Fiscal Year 2016


As required by the Generic Drug User Fee Amendments of 2012, FDA has announced the 2016 rates for the following user fees:

  • Abbreviated new drug application (ANDA),
  • Prior approval to an ANDA (PAS),
  • Type II active pharmaceutical ingredient drug master file (DMF),
  • Generic drug active pharmaceutical ingredient (API) facilities, and
  • Finished dosage form (FDF) facilities.

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

 

Need help deciding which application is right for your generic product? We can help you get through FDA successfully in a more time and cost efficient manner. To learn more about how we can help, please contact us


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