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doogdilinger

08/14/15 11:18 AM

#12847 RE: mopar44o #12840

Can't find the article off hand where I got the current 49 month average from so here's a link to a GPhA pdf from last month ok>>>

Since passage of GDUFA, OGD’s median review time to approval has continued to rise. When the program was negotiated in FY2011, median review time to generic approval was at 30 months. Since then, median review times increased to 31 months in FY2012, 36 months in FY2013, an estimated 42 months in FY2014 and between 48-50 months for FY2015



https://www.pharmamedtechbi.com/~/media/Supporting%20Documents/The%20Pink%20Sheet%20DAILY/2015/August/GPhA%20GDUFA%20renewal%20comment%20CLEAN%2081315.pdf