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Nature 571, 489499

Ulucan-Karnak, F

10.1038/s41593-019-0397-0 67 ChouchaniE

5, # 5, p

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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