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  • Regulatory NewsRegulatory News

    FDA Warns of One Death Linked to Fecal Transplants

    The US Food and Drug Administration (FDA) on Thursday warned medical and scientific communities and other interested persons of the potential risk of transmitting multi-drug resistant organisms (MDROs) via poop transplants, otherwise known as fecal microbiota for transplantation (FMT). FMT is typically used to help patients with the bacterium  Clostridium difficile who are not responding to standard therapies. 2013 guidance from FDA revealed that the agency intends t...
  • Regulatory NewsRegulatory News

    Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive

    The US Food and Drug Administration (FDA) on Monday announced new draft guidance that aims to further assure that patients infected with the bacterium Clostridium difficile and not responding to standard therapies can access poop transplants, also known as fecal microbiota for transplantation (FMT). FDA considers FMT an investigational new drug (IND), which requires physicians and scientists to file an IND application if they intend to use the treatment for clinical pr...
  • Regulatory NewsRegulatory News

    As Frozen Poop Pills Shown to be Effective in Study, FDA Policy in the Spotlight

    The US Food and Drug Administration (FDA) has a frozen poop problem, and it's getting messier with time. Background As Focus has explained in the past, FDA has been grappling with how to regulate an emerging medical procedure known as fecal microbiota transplantation (FMT) for several years. The procedure involves the transplantation of select fecal matter from one patient into another. While it may sound unusual, if not unsettling, emerging data show the procedure ...