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@article{2243005,
author = {Kubátová, Jana and Bell, Jennifer},
article_number = {4},
doi = {http://dx.doi.org/10.56012/dawh4648},
keywords = {faecal microbiota transplantation; regulatory aspects; clinical research; legislation},
language = {eng},
issn = {2047-4806},
journal = {Medical Writing},
title = {“All that is gold does not glitter”: Faecal microbiota transplantation},
url = {https://journal.emwa.org/open-science-and-open-pharma/biotechnology/},
volume = {31},
year = {2022}
}
TY - JFULL
ID - 2243005
AU - Kubátová, Jana - Bell, Jennifer
PY - 2022
TI - “All that is gold does not glitter”: Faecal microbiota transplantation
JF - Medical Writing
VL - 31
IS - 4
SP - 78-83
EP - 78-83
PB - European Medical Writers Association
SN - 20474806
KW - faecal microbiota transplantation
KW - regulatory aspects
KW - clinical research
KW - legislation
UR - https://journal.emwa.org/open-science-and-open-pharma/biotechnology/
N2 - The review focuses on faecal microbiota transplantation (FMT) from the regulatory point of view. The clinical use of FMT has been on the rise in recent years and is the subject of intensive, mostly non-commercial research. The legislative definition of FMT preparations and the requirements for stool donation in clinical practice and research are subject to regulation only at the national level. We find a non-uniform legislative approach to this issue even within the European Union. The work also outlines possible directions for commercial and non-commercial research and development and draws attention to the need for professional communication about FMT with regulators and the professional and lay public.
ER -
KUBÁTOVÁ, Jana a Jennifer BELL. “All that is gold does not glitter”: Faecal microbiota transplantation. \textit{Medical Writing}. European Medical Writers Association, 2022, roč.~31, č.~4, s.~78-83. ISSN~2047-4806. Dostupné z: https://dx.doi.org/10.56012/dawh4648.
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