Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

摘要

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. Matters considered at the meeting will include discussion of the toxicity risks of adeno-associated virus (AAV) vector-based gene therapy products. The discussion topics include oncogenicity risks due to vector genome integration and safety issues identified during preclinical and/or clinical evaluation. The meeting will be open to the public on both days. FDA is establishing a docket for public comment on this document.