GDUFA Stakeholder Deadline Extended; Are Talks Delayed?
This article was originally published in The Pink Sheet Daily
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.
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Generic drug user fee reauthorization talks remain on schedule and are expected to last about four months.
Generic user fees could be segmented further by addition of new group.
The finalized generic drug user fee agreement would clear most of the ANDA application backlog by the end of the first program cycle.