In May last year the US FDA declared Fecal Microbiota Transplant an Investigative New Drug and confined its use to patients with Clostridium Difficile whose condition had not responded to other treatments. It has now issued a draft guidance paper… Read More ›
Tag Archive for ‘FDA’
US Food & Drug Administration classifies FMT an Investigational New Drug
It’s been a glum week in the FMT facebook group this week following cancelled FMT procedures in the wake of the FDA’s classification of FMT as an Investigational New Drug (IND). This decision was confirmed in a letter from the FDA to… Read More ›