Search Results for MRT

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FDA: US Clinical Research Using Three-Parent Baby Technique is Illegal By Zachary Brennan - Published 07 August 2017

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.

Categories: News, US, FDA, Government affairs, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: mitochondrial replacement therapy, MRT, three parent baby technique, Leigh's syndrome,

Expert Committee: FDA Should Allow Mitochondrial Replacement Trials Under Certain Conditions By Zachary Brennan - Published 03 February 2016

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.

Categories: News, US, FDA, Biologics and biotechnology, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: MRT, mitochondrial DNA, inherited diseases, FDA regulation of MRT, CRISPR