FDA performs in-depth review of in vitro and animal studies (i.e., preclinical studies) before granting permission to commence clinical investigations with human subjects. In the case of MRT, it would be important to accumulate sufficient preclinical data on how the manipulation of gametes or embryos might affect the resulting embryos so as to reduce the risk of harm to children born as a result of MRT during clinical investigations. Preclinical research involving embryos of varying quality that would not be transferred would likely be necessary to produce the data necessary to protect future children.


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