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Home » FMT Qualifies as Biological Product, Requires IND Filing for Trials: FDA
FMT Qualifies as Biological Product, Requires IND Filing for Trials: FDA
May 22, 2013
The FDA recently informed a group of gastroenterological specialists that fecal microbiota transplantation (FMT), also known as a stool transplant, should be considered a biological product under agency oversight when treating Clostridium difficile (C. difficile) infection.