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Several intravenous iron formulations are available for the treatment of iron deficiency or RLS

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In accordance with 425.315(a)(2), good cause may be established when (i) there is new and material evidence that was not available or known at the time of the payment determination and may result in a different conclusion, or (ii) the evidence that was considered in making the payment determination clearly shows on its face that an obvious error was made at the time of the payment determination

BPC-157 does not have that approved-drug framework, and FDA has specifically identified safety and quality concerns for compounded drugs containing BPC-157 [16]