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 12th, 2013

FDA: Fecal Transplants Need Investigational New Drug Application

Gastroenterologists, ID doctors, C diff-sufferers, and microbiome-obsessed humanoids everywhere were treated to this surprising news recently — a decision by the FDA about fecal microbiota transplantation (FMT). From an email sent by the IDSA: Because fecal microbiota transplantation (FMT) is not approved for any therapeutic purposes, an investigational new drug (IND) application is needed for the […]

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March 31st, 2010

C diff Guidelines: Metronidazole Still Preferred?

IDSA and The Society for Healthcare Epidemiology of America (SHEA) have published Clinical Practice Guidelines for Clostridium difficile infection. Not surprisingly, it’s a comprehensive, extensively-referenced document that will be an invaluable resource, especially since the previous version is approximately 15 years old. But with the caveat that I’m not an expert in this area, these particular treatment recommendations […]

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September 18th, 2008

C. diff: The cure for antibiotic abuse

Even with market doom-and-gloom dominating the news, there’s a good article in yesterday’s Wall Street Journal on Clostridium difficile (C. diff).  It gives an accurate summary (in lay language) of the problem, several pertinent clinical anecdotes, and quotations from national experts. But this part in particular caught my eye: She says that among other measures, the hospital has […]

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