The Prescription Drug User Fee Act (PDUFA): A Primer

Posted 25 April 2017 By Valerie Fauvelle, MS, RAC, Meredith Brown-Tuttle, RAC, FRAPS

placeholder+image This article discusses key points and benefits of the Prescription Drug User Fee Act (PDUFA) for those filing a New Drug Application (NDA) and explains how PDUFA user fees have played an important role in expediting FDA's drug approval process.

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Categories: Biologics and biotechnology, Drugs, Submission and registration, News, US, FDA

Tags: User Fees, Prescription Drug User Fee Act, PDUFA

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