OTC Monograph User Fees Would Cut Review Time, Allow For IT Platform

By Beth Wang / June 22, 2017 at 8:36 PM
A draft document obtained by Inside Health Policy sets out expected performance goals for an over-the-counter monograph user fee program (OMUFA) under which FDA would see improved review timelines and more efficient review capacity by year four of the program. Assuming Congress enacts OMUFA and it goes into effect by Oct. 1, 2017, FDA and industry could expect to see an increase in OTC monograph review staff and reductions in review time, published draft and final guidance detailing processes, and...


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