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ANDA User Fee Performance Metrics Revealed

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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.

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.

ANDA User Fee Agreement Expected To Be Finished in Early September

FDA wants the commitment letter and draft legislation ready for internal clearance by Sept. 9.

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