BIO Comments on FDA Draft Guidance on Testing of Retroviral Vector-Based Human Gene Therapy Products
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-Up.
BIO agrees with most recommendations in the draft guidance on product testing for replication competent retrovirus (RCR).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In addition, BIO suggested passages in the draft guidance that could be clarified.