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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

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10.1111/odi.13727 211

doi.org/10.1210/er.2004-0014 Kojima, M., et al