The FDA has announced that it will not require an investigational new drug application for fecal microbiota as a treatment for C. difficile infections that do not respond to standard treatments, according to report by the American Gastroenterological Association.
No IND is required as long as physicians obtain informed consent from the patient.
Though the FDA does not require an IND, the agency urges physicians planning to use FMT to submit an IND first.
More Articles on Gastroenterology:
8 Statistics on GI Revenue in ASCs by Case Volume
ASGE Endoscopy Unit Recognition Program Recognizes 19 Endoscopy Units
Dr. Howard Hack Provides Care at Feather River Hospital in California