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  • Regulatory NewsRegulatory News

    FDA: US Clinical Research Using Three-Parent Baby Technique is Illegal

    The US Food and Drug Administration (FDA) said Friday that it is illegal to perform research in the US on a new type of technology that showed promise last year in helping a woman who had multiple miscarriages because of a genetic disorder to give birth to a baby boy in Mexico without that disorder. The technology, known as mitochondrial replacement technology (MRT), deals with mitochondrial DNA passed down only from mother to child. In September 2016, MRT was used to...
  • Regulatory NewsRegulatory News

    Expert Committee: FDA Should Allow Mitochondrial Replacement Trials Under Certain Conditions

    While the US Food and Drug Administration (FDA) sits on the fence over whether to approve preclinical or clinical trials using mitochondrial replacement techniques (MRT) to help prevent the transmission of certain diseases passed from mother to child, the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine came out with a new report on Wednesday detailing how it believes FDA should allow such trials and regulate them. Background ...