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U.S. Department of Health and Human Services

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.