The FDA has announced that fecal microbiota for transplantation is a biological product and drug, which will require an investigational new drug application to be submitted before use, according to an Infectious Disease Special Addition report.
FMT is currently used as a treatment for Clostridium difficile infection. The FDA's regulatory actions are intended to protect patients from unnecessary risk.
Many have criticized the FDA for enacting strict regulations of a treatment that, as of yet, has shown little negative consequence.
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FMT is currently used as a treatment for Clostridium difficile infection. The FDA's regulatory actions are intended to protect patients from unnecessary risk.
Many have criticized the FDA for enacting strict regulations of a treatment that, as of yet, has shown little negative consequence.
More Articles on Gastroenterology:
3 Benefits of Outsourcing Colonoscopy Prep
UHC Recruits Dr. Adam Hansen, Gastroenterology Specialists
AbbVie, Galapagos Partner to Test Possible Chrohn's Disease Drug