AGA ‘applauds FDA’ for first approved fecal microbiota biotherapeutic

Following FDA approval of the first fecal microbiota biotherapeutics for recurrent Clostridoides difficile, the American Gastroenterological Association summarized what this means for gastroenterologists and patients going forward.Aside from this approval, a press release noted the largest change to previous guidance is that the FDA will now require stool banks that provide fecal microbiota therapy products (FMT) to comply with investigational new drug requirements. In the meantime, health care professionals can continue use of appropriately screened donated stool for patients with recurrentRead More

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