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  1. Where Stool is a Drug: International Approaches to Regulating the Use of Fecal Microbiota for Transplantation.Alexandra Scheeler - 2019 - Journal of Law, Medicine and Ethics 47 (4):524-540.
    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.
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  • The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation.Alexander Khoruts, Diane E. Hoffmann & Francis B. Palumbo - 2019 - Journal of Law, Medicine and Ethics 47 (4):482-504.
    In this article, the authors explore the impact of a potential future regulatory decision by FDA whether or not to continue its enforcement discretion policy allowing physicians to perform, and stool banks to sell, stool product for fecal microbiota transplantation as a treatment for recurrent Clostridium Difficile infection without an Investigative New Drug application. The paper looks at the Agency's regulatory options in light of the current gut microbiota based products that are in the FDA pipeline for drug approval and (...)
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  • Introduction: The Promise and Challenges of Microbiome-Based Therapies.Diane E. Hoffmann - 2019 - Journal of Law, Medicine and Ethics 47 (4):476-481.
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