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Where Stool is a Drug: International Approaches to Regulating the use of Fecal Microbiota for Transplantation

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The investigational fecal microbiota transplantation (FMT) treatments discussed on this website and associated OpenBiome materials have been not been approved or licensed by the U.S. Food and Drug Administration or by any other regulatory authority, and it is not commercially available in any market. OpenBiome is acting only in the capacity of distributor of investigational FMT preparations manufactured by the University of Minnesota under an FDA-reviewed investigational new drug application (IND).

Before placing an order for any investigational FMT from OpenBiome/UMN, a licensed physician must submit a registration form, agree to comply with applicable regulatory requirements intended to safeguard the patients under their care, and be added as an investigator to the research IND that authorizes expanded access to the investigational biologic for appropriate patients.

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