BIO Comments on FDA Draft Guidance on Testing of Retroviral Vector-Based Human Gene Therapy Products
November 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-Up.
BIO agrees with most recommendations in the draft guidance on product testing for replication competent retrovirus (RCR). In particular, BIO commends the FDA for inviting the gene therapy community to publish findings of relevant studies, which will benefit and advance the field.
BIO suggests FDA convene a public workshop with industry, academia, and other stakeholders to discuss current scientific data regarding RCR in gene therapy applications. BIO would be happy to help FDA with this effort.
In addition, BIO suggested passages in the draft guidance that could be clarified.
Download Full Comments Below
FINAL BIO Letter Testing Of Retroviral Vector-Based GT Products For RCR 12-10-18
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-Up.
BIO agrees with most recommendations in the draft guidance on product testing for replication competent retrovirus (RCR). In particular, BIO commends the FDA for inviting the gene therapy community to publish findings of relevant studies, which will benefit and advance the field.
BIO suggests FDA convene a public workshop with industry, academia, and other stakeholders to discuss current scientific data regarding RCR in gene therapy applications. BIO would be happy to help FDA with this effort.
In addition, BIO suggested passages in the draft guidance that could be clarified.