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Nonetheless, the interpretation of these studies is complicated by the fact that these models are constitutive genetic deletions, and due to the lack of FA mobilization from adipocytes, these mice are completely reliant on glucose as a fuel source

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of this final rule with comment period, skin substitutes with an approved Biologics License Application (BLA) will be considered under transitional drug pass-through payment status and skin substitutes with FDA Premarket approval (PMA) or FDA 510(k) clearance will continue to be evaluated under transitional device pass-through payment status