Docket Number: FDA-2014-D-0852 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER)/Office of Cellular, Tissue, and Gene Therapies (OCTGT) is issuing this guidance to provide you, sponsors of virus or bacteria-based gene therapy products (VBGT products)1 and oncolytic viruses or bacteria (oncolytic
