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Re: markjohn62 post# 5841

Wednesday, 12/17/2008 8:16:26 AM

Wednesday, December 17, 2008 8:16:26 AM

Post# of 6489
>I wondered also if a FOB pathway could be found without major legislation, maybe some current rule tweaking.<

It already has been found—e.g. Omnitrope from NVS (#msg-11358021). But this kind of FoB approval (via the 505b2 pathway) will work only for the simplest kinds of protein drugs. Regards, Dew


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