Business · 29/11/2022

FDA Announces Enforcement Policy for Investigational New Drug Requirements for Fecal Microbiota Transplantation to Treat C. difficile Infection

The US Food and Drug Administration (FDA) has released a final guidance document outlining its enforcement policy for the use of fecal microbiota transplantation (FMT) to treat Clostridioides difficile (C. difficile) infection that is not responsive to standard therapies, allowing for limited enforcement discretion under specific circumstances.