FDA Announces Draft Guidance on Fecal Microbiota Transplantation for C. difficile Infection

Summary

The US Food and Drug Administration (FDA) has released a draft guidance outlining its enforcement policy for the use of fecal microbiota transplantation (FMT) to treat Clostridium difficile infection that is not responsive to standard therapies, with the condition that patients must provide informed consent and the donor and stool must be qualified through screening and testing.