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markjohn62

12/17/08 8:07 AM

#5841 RE: DewDiligence #5840

'That article is 2.5 years old.'

It was to just to show the large list of possible FOB targets. I hadn't seen a list like it before and found it interesting.

'
Looking naively at these definitions and not knowing anything about the manner in which the products are actually registered in the US, most people would instinctively classify recombinant protein products that are not vaccines, toxins, or antitoxins, as drugs, rather than biological products. However, the FDA actually classified some recombinant protein products as drugs and others as biological products. It did this by using administrative rulemaking to create a broad interpretation of the definition of biological product in the PHS Act'

I wondered also if a FOB pathway could be found without major legislation, maybe some curent rule tweaking.

Have a good one