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Title : Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Docket Number : FDA-1999-D-0081 Source : FDA Homepage (https://www.fda.gov/regulatory-information/search-fda-guidance-documents) 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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FDA-1999-D-0081.pdf




