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Re: DewDiligence post# 149641

Saturday, 09/29/2012 6:38:39 PM

Saturday, September 29, 2012 6:38:39 PM

Post# of 257580
Without the need to do separate trials for EMA, EU become an add on to US without incurring much additional development cost. FDA/EMA should harmonize for NDA/BLA/MAA as well to reduce the need to do separate trials for US and EU.

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