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Generic User Fees: Small Firms Might Get Waivers; CMOs Want Them Too

29 Sep 2014

GDUFA’s exemption-free design – unique among FDA user fees – is coming under increasing pressure as firms pay and wait for approval, but adding to the agency’s administrative burden would come at a cost as well.

As momentum builds to add a small business waiver to the generic drug user fee program, another group of manufacturers is looking to gain an exemption.

Contract manufacturers, some of which do very little work for generics companies, also want to avoid paying the GDUFA facility...