Business · 01/03/2016

FDA Drafts Enforcement Policy for Fecal Microbiota Transplantation for C. difficile Infection Treatment

The Food and Drug Administration (FDA) has released a draft document outlining its enforcement policy for Investigational New Drug (IND) requirements for using fecal microbiota transplantation (FMT) to treat Clostridium difficile (C. difficile) infections that are not responsive to standard therapies. The draft guidance aims to provide clarity on the agency's enforcement discretion for FMT use.