OTC Monograph User Fees Up To $34M Floated In Senate Discussion Draft

摘要

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. Total annual user fees of $22m to $34m from OTC manufacturers primarily from facility registrations are among the proposals in a discussion document circulated by Sens. Johnny Isakson, R-GA, and Bob Casey, D-PA.