HIV and ID Observations

June 19th, 2013

FDA, IND, FMT: Nine Letters, Some Common Sense, and a Real Video Link

Good news here — the FDA has reconsidered their requirement for an IND for fecal microbiota transplantation (FMT) for C diff: Some health care providers have stated that applying IND requirements will make FMT unavailable and have suggested that an alternative regulatory approach is needed to ensure the widespread availability of FMT for individuals with C. […]

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May 31st, 2013

Fecal Microbiota Transplantation — Try This At Home?

As noted before, the FDA says that an investigational new drug (IND) application is required for therapeutic use of fecal microbiota transplantation. The practical effect of this decision, at least at our institution, is to stop providing this service — it’s on hold pending those “internal discussions” planned by the FDA on the regulatory issues surrounding the procedure. Which […]

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