Federal Register Notice: FDA is making available a draft document: Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products. It provides sponsors of virus or bacteria-based gene therapy products and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical development. To download this guidance, click here. To view this notice, click here.