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News

Guidance on new drug applications for fecal microbiota transplantation studies 

A team of doctors provide guidance on preparing an investigational new drug application for fecal microbiota transplantation studies, as reported in the latest Clinical Gastroenterology & Hepatology.

News image

Fecal microbiota transplantation (FMT) is an effective treatment for Clostridium difficile infections that are refractory to antibiotic therapy.

Because of the important roles of the microbiota in the function of the gastrointestinal tract and other aspects of human physiology, Dr Colleen Kelly and colleagues from Rhode Island, USA reviewed the growing interest in studying FMT for other clinical indications.

The team report that the US Food and Drug Administration regulates clinical studies to evaluate the safety and efficacy of FMT.

Most academic physicians do not have the regulatory experience to undertake this process
Clinical Gastroenterology & Hepatology

Studies of FMT for recurrent Clostridium difficile infection or other indications could require submission of an investigational new drug application.

The team observed that most academic physicians and investigators do not have the regulatory experience necessary to undertake this process.

Dr Kelly and team concludes, "We provide guidance to researchers on the preparation and submission of investigational new drug applications to study FMT."

Clin Gastroenterol Hepatol 2014: 12(2): 283-288
31 January 2014

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