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sts66

10/19/17 11:48 AM

#116387 RE: HDGabor #116316

However it will be a scientific determination in every cases: Could anybody (ITC) made a scientific determination (based on FDA decision / precedence) or not?



I know this isn't a court case where prior case law is ironclad, but in my view precedence should still be available for ITC to use - FDA has previously determined synthetic non-naturally occurring substances are classified as drugs, so the scientific determination has already been made, ITC does not have to make their own independent decision on EE-EPA - just cite previous FDA rulings. Doesn't mean that's what's going to happen, of course, too logical/common sense when political turf wars are involved.