Generic Drugs Face Regulatory and Scientific Challenges

Wechsler, Jill
August 2013
BioPharm International;Aug2013, Vol. 26 Issue 8, p10
Trade Publication
The article discusses legislative, regulatory and scientific challenges facing the generic drugs sector. The developments in the sector as the U.S. Food and Drug Administration (FDA) celebrates the one-year anniversary of the Generic Drug User Fee Amendments (GDUFA) of 2012 are discussed. The GDUFA steering committee is shifting its focus to enhance the generic-drug review performance to meet the performance commitments.


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