GDUFA I
The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. The law requires industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. Additional resources will enable the Agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.
- GDUFA I Negotiation Sessions
- February 28, 2011 Session (PDF - 29KB)[ARCHIVED]
- March 18, 2011 Session (PDF - 30KB)[ARCHIVED]
- March 31, 2011 Session (PDF - 24KB)[ARCHIVED]
- April 14, 2011 Session (PDF - 32KB)[ARCHIVED]
- April 28, 2011 Session (PDF - 29KB)[ARCHIVED]
- May 11, 2011 Session (PDF - 28KB)
- May 26, 2011 Session (PDF - 33KB)
- June 9, 2011 Session (PDF - 29KB)
- June 24, 2011 Session (PDF - 27KB)
- June 30, 2011 Session (PDF - 37KB)
- Combined July 14, 21 and 28, 2011 Sessions (PDF - 46KB)
- August 11, 2011 Session (PDF - 22KB)
- August 18, 2011 Session (PDF - 14KB)
- August 31, 2011 Session (PDF - 27KB)
- September 9, 2011 Announcement of Ratification and Next Steps (PDF - 23KB)
- GDUFA I Meetings and Updates
The Food and Drug Administration (FDA) held a series of public meetings to gather stakeholder input on the development of the generic drug user fee program.
- GDUFA Public Hearing on Policy Development
- Generic Drug User Fee (GDUF) Public Meeting: September 17, 2010[ARCHIVED]
- December 20, 2010 Stakeholder Update (PDF - 42KB)[ARCHIVED]
- Generic Drug User Fee (GDUF) Stakeholder Update: February 23, 2011[ARCHIVED]
- Generic Drug User Fee (GDUF) Public Meeting: May 10, 2011[ARCHIVED]
- Generic Drug User Fee (GDUF) Public Meeting: August 25, 2011
- Generic Drug User Fee (GDUF) Public Meeting: December 19, 2011[ARCHIVED]
- FDA Small Business Regulatory Education for Industry (REdI) Conference Fall 2012, September 19-20, 2012[ARCHIVED]
- Generic Drug User Fee Amendments of 2012 (GDUFA) Public Meeting: September 21, 2012[ARCHIVED]
- CDER Small Business Webinar on the Generic Drug User Fee Amendment (GDUFA) – User Fees and More - October 22, 2012[ARCHIVED]