GDUFA III: US FDA Says Generic Drug Supplement Volume Could Require More Resources
Will the growing workload cause GDUFA fees to increase or prompt other changes?
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Revenue increases are expected in FY 2021 over pre-pandemic estimates, in part because the US FDA believes sponsors may have applications that were delayed by COVID-19.
While the prescription drug user fee agreement between industry and the US FDA is almost done, generic renewal talks remain ongoing, and biosimilar talks have not started.
As GDUFA III negotiations continue, FDA doesn’t seem ready to make additional changes to approval process, but industry argues guidance practices and communications need fixing and that consumers are missing out on potential savings because of it.