Generic Drug User Fee (GDUFA): Proposed Changes for 2019

Generic drug user fee makes it possible for FDA and industry to ensure that the public has access to safe and high quality generic drugs and drug products.

The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the scope of regulating the generic drug industry. Generic drug user fee act was reauthorized on August 18, 2017 (GDUFA II), with provisions that go into effect from October 1, 2017 and remain in effect through September 30, 2022.

FY 2019 & 2018 user fee rates:

 

User Fee Type FY 2019 FY 2018
ANDA  $ 178,799  $ 171,823
DMF  $ 55,013  $ 47,829
Program Large Size  $ 1,862,167  $ 1,590,792
Medium Size  $ 744,867  $ 636,317
Small Size  $ 186,217  $ 159,079
Facility Domestic API  $ 44,226  $ 45,367
Foreign API  $ 59,226  $ 60,367
Domestic FDF  $ 211,305  $ 211,087
Foreign FDF  $ 226,305  $ 226,087
Domestic CMO  $ 70,435  $ 70,362
Foreign CMO  $ 85,435  $ 85,362
Backlog  $ 17,434  $ 17,434
PAS    

 

For further information please refer:*The one-time backlog fee was set in FY 2013 only. Those who have not paid for the incurred backlog fee may email CDERCollections@fda.hhs.gov for further assistance.

https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm