JG BioConsult, LLC

CMC, GMP and Quality Consulting for the Biotech Industry

Guidance for replication competent retrovirus

There is a new FDA Guidance for testing of replication competent retrovirus during product manufacture and patient follow-up. It is an interesting guidance, and it can be found at:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/testing-retroviral-vector-based-human-gene-therapy-products-replication-competent-retrovirus-during

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