For Industry
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GDUF Negotiation Sessions
Negotiation sessions between the FDA and industry began on February 28, 2011. The purpose of these meetings is to discuss logistics and expectations for establishment of a user fee program from the generic drug industry and related industry associations to support goals for the FDA’s generic drug user program.
Minutes from these negotiations will be posted on the FDA Web site approximately 10 business days after each session.
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FDA-Industry Generic Drug User Fee (GDUF) Negotiations Meeting Minutes
- February 28, 2011 Session (PDF - 29KB)
- March 18, 2011 Session (PDF - 30KB)
- March 31, 2011 Session (PDF - 24KB)
- April 14, 2011 Session (PDF - 32KB)
- April 28, 2011 Session (PDF - 29KB)
- 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)
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