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FMT and Microbial Medical Products: Generating High-Quality Evidence through Good Governance

Published online by Cambridge University Press:  01 January 2021

Pilar N. Ossorio  and
Yao Zhou
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Abstract

This article argues that current data for the safety and efficacy of fecal microbiota transplants as a treatment for any indication, including recurrent Clostridioides difficile infection, is low-quality. It develops a governance proposal that encourages production of high-quality evidence by incentivizing well-designed RCTs of stool and stoolderived microbial products. The proposal would require that FDA change its current enforcement approach, but it would not require any change in statutes or regulations.

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. 505 - 523
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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