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    The US Food and Drug Administration (FDA) on Monday announced new draft guidance that aims to further assure that patients infected with the bacterium Clostridium difficile and not responding to standard therapies can access poop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

    FDA’s CBER Questions US Transplant Technology Company

    The US Food and Drug Administration (FDA) is taking issue with Arizona-based Pinnacle Transplant Technologies for manufacturing a number of proprietary amniotic membrane-based products that FDA believes should be classified and approved as biologics. Pinnacle, according to its website , currently manufactures and distributes morselized amniotic membrane-based products, which FDA says are intended to treat soft tissue injuries and inflammation, to cover and protect wou...
  • Regulatory NewsRegulatory News

    HHS Establishes Organ Donation Policy for Patients With HIV

    The US Department of Health and Human Services (HHS) has unveiled new regulations to establish a parallel system of organ donation intended to serve patients with the human immunodeficiency virus (HIV). Background The regulations come almost a year and a half after US President Barack Obama signed into law the HIV Organ Policy Equity (HOPE) Act of 2013 . The law, passed in November 2013, modified the National Organ Transplant Act (NOTA) of 1984 by permitting HIV-p...
  • 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...
  • US HRSA Proposes Regulating Face, Hand Transplants

    The US Health Resources Services Administration (HRSA) wants to regulate face, hand, and other body part transplants much like it does for other organ transplants, according to the Washington Post . HRSA's proposal would also institute: waiting lists run by the United Network for Organ Sharing (UNOS); donor matching systems; organ distribution systems; and systems to test for diseases and infections. HRSA officials noted that they were seeking to issue the...