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The said petition must be accompanied by a copy of the validly issued CPR, clear and comprehensive photographic evidence of the compliant product in its final commercial presentation, and a copy of the subject FDA Advisory for official verification and validation

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2,6 and [ 13 C]-bicarbonate, which allows assessment of tumor pH.(7) Although these hyperpolarized substrates probe a wide range of biological processes, there are currently no hyperpolarized substrates that report directly on tumor redox status