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FDA reviewers, applying the statutory framework under 21 CFR 216.23(c), identified only one human study for BPC-157's proposed indication of ulcerative colitis: a decades-old meeting abstract that was never published as a peer-reviewed trial and that used an oral route of administration — not the injectable or subcutaneous routes that wellness clinics commonly use

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[DOI] [PMC free article] [PubMed] [Google Scholar] 90.Baker LD, Barsness SM, Borson S, Merriam GR, Friedman SD, Craft S, and Vitiello MV