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

 
• By Malcolm Spicer

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.

Capitol House

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.

Fees would also be raised when companies request changes via the monograph system. While the proposal does not detail the amounts collected from registering manufacturing facilities with FDA versus requesting...

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