Generic Drug User Fee (GDUFA): Proposed Changes for 2018

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 2018 user fee rates:

ANDA $171,823
Program Large $1,590,792
Medium $636,317
Small $159,079
DMF $47,829
Facility Domestic API $45,367
Foreign API $60,367
Domestic FDF $211,087
Foreign FDF $226,087
Domestic CMO $70,362
Foreign CMO $85,362
Backlog* $17,434
PAS N/A

*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.

For further information please refer:
https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm