OTC Monograph User Fee Goals Document Beats Authorization To Finish Line
This article was originally published in The Pink Sheet
While still awaiting the addition of OTC user fees to pending user fee authorization, and congressional approval of the overall package, FDA has developed guidelines closely tracking Sens. Isakson and Casey's OTC proposal. FDA plans a webinar to update industry on how OTC user fees would work.
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Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.