FDA User Fee Programs

Posted 08 May 2017 By Denise Gottfried MS, MBA, RAC, Patricia Maguire, PhD, Angeline Chooi, Adam Eldridge, PhD, Jonathan Gottfried, MBA

placeholder+image This article provides an overview of upcoming important changes to FDA's major user fee programs (PDUFA VI, MDUFA IV and GDUFA II) for Fiscal 2018–2022. It discusses new performance goals, additional commitments FDA has agreed upon with industry and how these changes could impact various types of industry submission strategies.

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Categories: Biologics and biotechnology, Generic drugs, Medical Devices, Submission and registration, News, US, FDA

Tags: User Fees, PDUFA, MDUFA, GDUFA

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