Generic User Fee Talks: Performance Metrics For Early Years Still Unresolved
Executive Summary
Industry and FDA appear largely in agreement on goals for the generic drug user fee program after it gets off the ground, but are stuck on how to determine agency performance in its early years.
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ANDA User Fee Negotiations Finished; Backlog To Be Mostly Cleared By Year Five
The finalized generic drug user fee agreement would clear most of the ANDA application backlog by the end of the first program cycle.
Generic Drug User Fees Will Begin With The Backlog
FDA set aside fears that a separate fee for the application backlog would create administrative problems for its generic drug user fee program, instead choosing to use the queue of pending submissions to help gain more funding at launch.