• 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    The US Food and Drug Administration (FDA) on Monday announced new draft guidance that aims to further assure that patients infected with the bacterium Clostridium difficile and not responding to standard therapies can access poop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

    German Regulators Decry Lack of Trial Transparency in Look at Stem Cell Transplantation

    The German Institute for Quality and Efficiency in Health Care (IQWiG) has found recent clinical data on the use of stem cell transplantation to treat multiple myeloma—a rare and deadly form of cancer—to be inconclusive . Background and 2012 Conclusion Stem cell transplantation is a therapy used to treat certain cancers, immunodeficiencies and hematologic diseases. It has also been widely used to treat multiple myeloma. Patients undergoing stem cell transplantation a...
  • 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 ...
  • Feature ArticlesFeature Articles

    Fecal Transplant—a Very Unusual Treatment Method

    Could anyone imagine a medical condition that would warrant administering a stool specimen from a donor? Such treatment would seemingly belie the "Above all, do no harm" axiom thought to be part of the Hippocratic oath. 1 It just so happens that such treatment first occurred more than 50 years ago, and continues today. In 1958, doctors in Denver, Colorado, administered donor feces by enema to patients with fulminant, life-threatening pseudomembranous enterocolitis, an ac...