Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products – FDA

Published August 2015 Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products 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 […]

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