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  1. FMT and Microbial Medical Products: Generating High-Quality Evidence through Good Governance.Pilar N. Ossorio & Yao Zhou - 2019 - Journal of Law, Medicine and Ethics 47 (4):505-523.
    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.
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  • 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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