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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GDUFA II Negotiations: Contract Manufacturers Gain Seat At Table
Generic user fees could be segmented further by addition of new group.
Generic User Fees Would Create 10-Month ANDA Review Time
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.
Generic User Fees Get Another Hearing As FDA Seeks More Public Comment
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.