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Alias Born 01/26/2012

Re: DewDiligence post# 8677

Wednesday, 02/22/2012 10:00:34 AM

Wednesday, February 22, 2012 10:00:34 AM

Post# of 20689
Read the slide about the transition to 351. In the cases where products are redefined, the FDA needs to stipulate which regulatory framework to follow.

I think you are underestimating the amount of change that will happen from the new biologics pathway... the very terms with which you speak are being redefined. The pathway will affect products that were previously not considered biologics, which ones I do not know.