Chronic C.difficile can be a serious complication in CLL... and fectal transplants have saved lives...
Researchers who have been reporting success with the use of fecal transplant to treat resistant C. difficile are likely to need an OK from the the FDA to continue that treatment.
The reason the FDA is stepping into the "poop" involves the way in which the agency interprets existing regulations that cover biologic drugs. Fecal microbiota, it said, meets the definition of a biologic product and such products require an IND (Investigational New Drug (IND) Application) before they are tested in humans.
Synthetic poop from Canada... it might be a drug, but the real stuff??