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Staff cited inadequate substance characterization, uncertain product quality, insufficient evidence of effectiveness for ulcerative colitis, sparse human safety data, and unresolved risks such as immunogenicity, aggregation, impurities, and long-term exposure
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10.1016/j.jmig.2006.07.013 26 DengX.SzaboS.KhomenkoT.TolstanovaG.PaunovicB.FrenchS
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In contrast, treatment for Stimulant Use Disorder remains an area of significant unmet need, as no FDA-approved medications currently exist