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


FDA Office of Communication, Outreach 23 and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring,

Document Type:
Draft Guidance
recommendations regarding the testing for RCR during the manufacture of retroviral vector-based gene therapy products, and during follow-up monitoring of patients who have received 82 retroviral vector-based gene therapy products. Recommendations include the identification and amount of material to be tested as well as general testing methods. In addition, recommendations are provided for monitoring patients for evidence of retroviral infection after administration of retroviral vector-based gene therapy products.

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