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

Published online by Cambridge University Press:  01 January 2021

Alexandra Scheeler
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Abstract

Regulatory agencies vary widely in their classification of FMT, with significant impact on patient access. This article conducts a global survey of national regulations and collates existing FMT classification statuses, ultimately suggesting that the human cell and tissue product designation best fits FMT's characteristics and that definitional objectives to that classification may be overcome.

Type
Symposium 1 Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 4: Symposium 1 - The Promise and Challenges of Microbiome-based Therapies. Symposium 2 - Regulation on International Direct-to-Participant Genomic Research , Winter 2019 , pp. 524 - 540
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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