FDA Generic, Biosimilar User Fees Could Be Locked Up Under Short-Term Funding Bill
This article was originally published in The Pink Sheet Daily
A continuing resolution does not specifically allow FDA to spend the fees, but the generic drug backlog and biosimilar product development fees are expected to be available.
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FDA and advocates wait for OMB to clarify how the estimated 7.8% budget cut should be implemented, if it is enacted. Former agency officials say it could lead to hiring freezes and program delays.
A new guidance includes preliminary estimates of backlog, application and drug master file fees under the new generic drug user fee program. However, the agency must wait for Congress to pass an FY 2013 appropriations bill or continuing resolution with language allowing it to collect the new revenue.
A Federal Register notice outlines the new user fee amounts and suggests that President Obama’s budget projections anticipated as many as 10 marketing applications, but the mix of INDs and full applications is unknown.