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Quantitation of AAV-Based Gene Therapy Products Workshop

  • Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 USA (map)

The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research will be holding a public workshop to discuss best practices when measuring the concentration of AAV vectors and to provide FDA perspective on qualifying such assays. The workshop will bring together academia, industry, and other stakeholders involved in research, development, and regulation of AAV-Based gene therapy products.