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dc.contributor.authorHoffmann, D.E.
dc.contributor.authorPalumbo, F.B.
dc.contributor.authorRavel, J.
dc.date.accessioned2019-11-01T12:49:35Z
dc.date.available2019-11-01T12:49:35Z
dc.date.issued2017
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85015812273&doi=10.1080%2f19490976.2017.1293223&partnerID=40&md5=8df2e42d9093288ab315dd7c8b442c61
dc.identifier.urihttp://hdl.handle.net/10713/11287
dc.description.abstractThe advent of fecal microbiota transplantation (FMT) and the prospect of other types of microbiota transplants (MT), e.g. vaginal, skin, oral and nasal, are challenging regulatory agencies. Although FDA is regulating FMT (as a biologic), there is currently no widely accepted or agreed upon scientific or legal definition of FMT or MT. The authors report on discussions regarding a definition of MT that took place among a working group of stakeholders convened under a National Institutes for Allergies and Infectious Diseases grant to address the regulation of MT. In arriving at a definition, the group considered the 1) nature of the material being transplanted; 2) degree of manipulation of the transferred materials prior to implantation; 3) ability to characterize the transplanted product using external techniques; and 4) origin of the stool product (single vs multiple donors). Copyright 2017 The Author(s). Published with license by Taylor & Francis Copyright 2017, Copyright Diane E. Hoffmann, Francis B. Palumbo, Jacques Ravel, Virginia Rowthorn, and Erik von Rosenvinge.en_US
dc.description.urihttps://doi.org/10.1080/19490976.2017.1293223en_US
dc.language.isoen_USen_US
dc.publisherTaylor and Francis Inc.en_US
dc.relation.ispartofGut Microbes
dc.subjectdefinitionen_US
dc.subjectfecalen_US
dc.subjectmicrobiota transplantationen_US
dc.subjectregulationen_US
dc.titleA proposed definition of microbiota transplantation for regulatory purposesen_US
dc.typeArticleen_US
dc.identifier.doi10.1080/19490976.2017.1293223
dc.identifier.pmid28318396


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