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March 02, 2017

GDUFA II is Coming: What it Means for West's Generics Customers

<p style="margin: 0in 0in 10pt;"><span>When the first Generic Drug User Fee Act (GDUFA I) was enacted in 2012, The FDA&rsquo;s Office of Generic drugs (OGD) was trying to&nbsp;manage a growing backlog of regulatory applications. The introduction of user fees to the generic drug approval process permitted FDA to increase resources to address the increasing review and inspection demands. In addition, GDUFA I set forth performance goals for the FDA over a 5-year span, resulting in reductions in both the generic drug application backlog and application review times. </span></p>
Steve LoCastro

Steve LoCastro

Director, Regulatory Affairs


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