FDA: Fecal Transplants Need Investigational New Drug Application

In his blog HIV and ID Observations, Dr. Paul Sax weighs in on a recent FDA decision regarding fecal microbiota transplantation.

Because fecal microbiota transplantation (FMT) is not approved by the FDA for any therapeutic purposes, the agency is requiring an investigational new drug application to use FMT to treat any disease. Although Dr. Paul Sax understands the FDA's perspective, he says in his HIV and ID Observations blog, the immediate practical effect of this decision is that getting FMT to the patients who need it — those with recurrent Clostridium difficile infection — will now be much more difficult.

FDA: Fecal Transplants Need Investigational New Drug Application

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