FDA Issues Final Guidance on Use of Fecal Microbiota for Transplantation

The FDA is not extending its enforcement discretion policy for Investigational New Drug (IND) requirements governing the use of fecal microbiota for transplantation (FMT) obtained from stool banks for treatment of C. difficile infection that is not responding to standard therapy, the agency said in a final guidance released yesterday.
Source: Drug Industry Daily