FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products

Daniel Eisenman and Scott Swindle authored the article “FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products” in Applied Biosafety.

The U.S. regulatory environment is evolving to accommodate a boom in gene therapy research. The 2019 version of the National Institutes of Health (NIH) Guidelines on Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) lacks an appendix providing specific guidance for institutional biosafety committee (IBC) review of clinical trials. As the field matures, the burden of federal oversight for clinical trials of investigational products containing recombinant or synthetic nucleic acid molecules is shifting toward the Food and Drug Administration (FDA).

This report summarizes recent FDA guidance documents on shedding and considerations for environmental impact assessments highlighting key points pertinent to IBC review. Knowledge of the guidance documents discussed in this report will assist biosafety professionals in understanding the evolving regulatory framework for gene therapy products. Additionally, this report addresses issues pertaining to shedding and environmental impact during IBC review of clinical trials.

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