September 20, 2018

FDA Workshop on Fecal Microbiota Transplantation May 2013

Here is a link to the FDA workshop on Fecal Microbiota Transplantation which was held May 2-3, 2013.

After this workshop the FDA announced that requirements that doctors had to get Investigational New Drug (IND) permits before performing fecal transplants would be more strictly enforced. After pushback from patients and doctors during and after this meeting the FDA later reversed course and decided to exercise “enforcement discretion.” Basically meaning that they would not enforce the IND rules.