Generic Drug User Fee Act (GDUFA): Overview and Proposed Changes for 2018

Posted 11 May 2017 By Karla Mark-Lantz, PhD

placeholder+image This article discusses aspects of the Generic Drug User Fee Act enacted by Congress as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), including fees, changes enabling FDA to speed up reviews, GDUFA goals and proposed changes and impacts as the first five–year phase concludes in 2017.

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Categories: Generic drugs, Submission and registration, Features, US, FDA


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