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They arent FDA-approved, meaning they havent undergone the FDAs review process for safety, effectiveness, or manufacturing quality as commercially made drugs do

10.3748/wjg.v20.i5.1192 45 HoylesL.Fernndez-RealJ.-M.FedericiM.SerinoM.AbbottJ.CharpentierJ.et al (2018)

Analysis of intestinal microflora and metabolites from mice with DSS-induced IBD treated with Schistosoma soluble egg antigen

Off-label prescribing may occur, but diagnosis, insurance and clinical considerations differ

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