FDA Policy/General

Guidance on INDs for Fecal Microbiota Transplants

Federal Register Notice: FDA is making available a draft document entitled Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Draft Guidance for Industry. It provides members of the medical and scientific community and other interested persons with notice that, when finalized, we intend to exercise enforcement discretion under limited conditions, on the investigational new drug requirements for using fecal microbiota for transplantation to treat C. difficile infection not responding to standard therapies. It replaces a guidance of the same title dated 3/2014 and when finalized is intended to supersede the document of the same title dated 7/2013. To download this guidance, click here. To view this notice, click here.

Guidance on INDs for Fecal Microbiota Transplants

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