Mark V. Sauer
A Missed Opportunity: FDA and Mitochondrial Manipulation Technology
On February 25th and 26th2014 the Federal Drug Administration(FDA) convened a Cellular, Tissue and Gene Advisory Committee meeting in Gaithersburg, Maryland. The stated purpose of this meeting was to review basic and clinical research related to “Oocyte modification in Assisted Reproduction for the Prevention of Mitochondrial Disease or Treatment of Infertility”, in order to make recommendations regarding the proper conduct of proposed future clinical trials. The meeting was public, and in addition to the invited presentations of expert scientists in the field, an Open Public Session forum in which participants were given 4 minutes to speak was included. The national press corps was also in attendance and the meeting was highly reported in both written and visual media outlets. .
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