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OTC Monograph User Fee Goals Document Beats Authorization To Finish Line

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.

FDA entrance sign 2016

FDA is ready with a procedures and performance goals document for an OTC monograph user fee program even though language establishing the program has not been added to legislation pending in Congress to reauthorize the agency's existing drug and medical device user fees.

The agency also on July 27 announced a webinar scheduled for Aug. 23 to discuss the document and to update industry stakeholders on progress in the initiative to consider user...

FDA Commissioner Scott Gottlieb has said FDA "reasonably" expects timely reauthorization of the drug and medical device user fee programs by Congress before the end of fiscal 2017, Sept. 30....

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