Generic User Fees: Small Firms Might Get Waivers; CMOs Want Them Too
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.
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Since applications comprise most of the workload, they will be the focus in the next generic drug user fee cycle.
Small business owners say the GDUFA facility and other fees are too expensive, especially while waiting for ANDAs to be approved, but any small business waiver is unlikely until GDUFA II.
FDA says it likely will oppose the provision because it would create more administrative complexity and increase fees paid by individual firms, but many provider and professional associations think waivers could help prevent and alleviate drug shortages.