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
