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Replies to post #12840 on Intellipharmaceutics International Inc. (IPCI)
doogdilinger
08/14/15 11:18 AM
#12847 RE: mopar44o #12840
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