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The committees recommendation is advisory, and the FDA will now review the recommendation, public comments and the administrative record before determining whether to move forward with rulemaking

With regard to the commenters' concerns regarding clinically relevant relationships, we emphasize that we continue to believe that the nature of the PFS relative value system is such that all services are appropriately subject to comparisons to one another

Because of their malfunctioning kidneys and renal clearance, the B12 remained in the blood, and serum values rose from an average of 422pmol/L to 54,000pmol/L, without side effects

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