GDUFA III: How Much Of A Fee Increase Can Industry Stomach?
Amid questions about generic industry market dynamics, the user fee renewal could focus on limiting increases in US FDA collections.
You may also be interested in...
Will the growing workload cause GDUFA fees to increase or prompt other changes?
Talks between US FDA and industry to extend the generic drug and prescription drug user fee programs may last into 2021.
Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.