Fecal transplantation poses dilemma for FDA

@article{Ratner2014FecalTP,
  title={Fecal transplantation poses dilemma for FDA},
  author={Mark Ratner},
  journal={Nature Biotechnology},
  year={2014},
  volume={32},
  pages={401-402}
}
401 New England Journal of Medicine in January 2013 (NEJM 368, 407–415, 2013). The study was stopped early when C. difficile-associated diarrhea resolved in 13 of the 16 patients in the FMT-treated group, after a single infusion. Two of the three remaining patients were also cured after repeating the procedure. For the FDA, fecal transplant fits the definition of a biological agent and not transplanted tissue. In an April 2013 letter to the American Gastroenterological Association (AGA), it… CONTINUE READING
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