ANDA User Fee Negotiations Finished; Backlog To Be Mostly Cleared By Year Five
Executive SummaryThe finalized generic drug user fee agreement would clear most of the ANDA application backlog by the end of the first program cycle.
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Generic drug user fee reauthorization talks remain on schedule and are expected to last about four months.
FDA says stakeholders who want to participate in monthly updates during formal generic drug user fee talks have until late April 2016 to give notice, prompting questions about the negotiation schedule.
Small business owners say the GDUFA facility and other fees are too expensive, especially while waiting for ANDAs to be approved, but any small business waiver is unlikely until GDUFA II.