Guidance on preparing an investigational new drug application for fecal microbiota transplantation studies

Faecal microbiota transplantation (FMT) has emerged as an effective treatment for Clostridium difficile infections that were stubborn to antibiotic therapy. However, other clinical indications of FMT are receiving an increasing attention due to the relevant roles of the microbiota in the function of the gastrointestinal tract and other aspects of human physiology. In consequence, studies of FMT for recurrent Clostridium difficile infection or other indications could require submission of an investigational new drug (IND) application.

An IND application is required in the United States by the US Food and Drug Administration (FDA). The FDA regulates clinical studies to evaluate their safety and efficacy, and the IND is necessary whenever clinical studies are initiated on a new drug, or for a new indication or different route of administration of an already approved drug.

Most physicians and investigators could not have the regulatory experience necessary to undertake this process. On this video abstract, Dr. Kunde outline the basic elements to consider for an Investigational New Drug (IND) application, summarizing the article published in the Clinical Gastroenterology Hepatology journal by him and his co-workers. The article provides guidance to researchers, in which the authors specifically detailed the preparation and submission of investigational new drug applications to study fecal microbiota transplantation (FMT).

Kelly CR et al. (2014) Guidance on preparing an investigational new drug application for fecal microbiota transplantation studies Clinical Gastroenterology Hepatology 12(2), pp. 283-288. doi:10.1016/j.cgh.2013.09.060

 

GMFH Editing Team
GMFH Editing Team