FDA issues final guidance on the design and analysis of shedding studies

Following a consultation period, the FDA’s Center for Biologics Evaluation and Research (CBER)/Office of Cellular, Tissue, and Gene Therapies (OCTGT) has issued a finalised Guidance for Industry document to provide sponsors of virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical development. For purposes of this guidance, the term “shedding” means release of VBGT or oncolytic products from the patient through one or all of the following ways: excreta, secreta, or through the skin.

The guidance addresses the following topics:

  • Why collect shedding data during product development?
  • Collection of shedding data in preclinical studies
  • Design of shedding studies: guiding principles
  • Collection of shedding data in clinical studies
  • Analytical assays to measure shedding
  • Analysis of shedding data
  • Analysis of shedding data
  • Assessing the potential for transmission to untreated individuals due to shedding

Author: Patrick Ginty.