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Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up

Abstract:

This guidance document applies to the manufacture of gene therapy retroviral vector products intended for in vivo or ex vivo use and to follow-up monitoring of patients who have received retroviral vector products.

Type:
Report
Date:
Site link:
Read the Report: Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up
URL Citation:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/testing-retroviral-vector-based-human-gene-therapy-products-replication-competent-retrovirus-during
LawSeqSM Record Last Modified:
04/13/2026