BIO Comments on Draft Guidance on Long-Term Follow-Up After Administration of Human Gene Therapy Products
November 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Long-Term Follow-Up After Administration of Human Gene Therapy Products.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.
Download Full Comments Below
FINAL BIO Letter LTFU After Administration Of GT Products 12-10-18
Dear Mr. Thune, Mr. Schumer, Mr. Johnson, and Mr. Jeffries:As President and CEO of the Biotechnology Innovation Organization (BIO), as a father and entrepreneur whose family is here today because of biotech innovation, and on behalf of the more than…
Chairman Griffith, Chairman Guthrie, Ranking Member DeGette, Ranking Member Pallone, and distinguished members of the subcommittee, thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO)…
Dear Congressional Leaders:On behalf of the Council of State Bioscience Associations (CSBA)—a national coalition of independent, state and territory-based organizations representing the full breadth of America’s biotechnology ecosystem—we write to…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Long-Term Follow-Up After Administration of Human Gene Therapy Products.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.