BIO Comments on Draft Guidance on Long-Term Follow-Up After Administration of Human Gene Therapy Products
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Long-Term Follow-Up After Administration of Human Gene Therapy Products.
BIO says the guidance reflects the FDA’s experience evaluating the safety of gene therapy products over the past decade. In addition, the guidance provides important recommendations on how to determine and develop long-term follow-up after the administration of human gene therapy products.
BIO provides general and detailed comments on a number of issues, including the safety risk and viral vector of gene therapy products, logistical challenges of long-term follow-up periods and the need to work with sponsors to develop best practices, the importance of partnering with stakeholders on biodistribution questions, and the importance of harmonization with global, multilateral organizations in the field.