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FDA's evaluation concluded that the criteria weighed against placement on the list, citing inadequate physicochemical characterization, immunogenicity concerns from impurities and aggregates, lack of clinical effectiveness data for any approved use, and absence of published human exposure data for the proposed subcutaneous and topical routes

1 If anti-intrinsic factor results are negative but suspicion for pernicious anemia remains, an elevated serum gastrin level is consistent with the diagnosis

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