GDUFA Talks: FDA Reminds Industry The Program Is Generic-Only
Generic drug user fee negotiations began with a reminder that components of the program will not apply to other regulated drug sectors.
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Generic user fees could be segmented further by addition of new group.
Annual revenue of $250 million to $300 million in generic drug user fees is discussed as FDA unveils its "four walls and a roof" guiding principles.
The agency may not feel all industry sector voices have been heard and wants to provide another opportunity for input at the May 10 session, but negotiations with GPhA and API groups are continuing.