Enforcement Policy Regarding Investigational New Drug (IND) Requirements for Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies

28 November 2022 – FDA published its policy on IND requirements for FMT use.

The FDA is informing members of the medical and scientific community and other interested persons of the policy regarding the investigational new drug application (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat Clostridioides difficile (C. difficile) infection not responding to standard therapies. At this time, FDA intends to exercise enforcement discretion with respect to such requirements under limited circumstances as described in section II of this guidance.

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