Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA)
Conclusion and Summary
Purpose and Key Outcomes of GDUFA

The purpose of GDUFA is to help FDA ensure that participants of the U.S. generic drug system comply with U.S. quality standards, and to increase the likelihood that American consumers get timely access to low cost, high quality generic drugs.

Understanding GDUFA.  Generic Drug User Fee Amendments.
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