Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Public Hearing; Request for Comments

摘要

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing to obtain input on the use of fecal microbiota for transplantation (FMT) to treat Clostridium difficile infection not responsive to standard therapies. FDA will consider scientific data and other information from the public hearing as we continue to consider ways to support the development of FMT to treat C. difficile infection not responsive to standard therapies and the impact of the enforcement policy on such development.