Cellular, Tissue and Gene Therapies Advisory Committee - 2/26/2014

The committee will discuss oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility. Also, the committee will hear updates on guidance documents issued from the Office of Cellular, Tissue, and Gene Therapies, Center for Biologics Evaluation and Research (CBER), FDA as well as discussing considerations for the design of early-phase clinical trials of cellular and gene therapy products.