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# Draft Guide on Retroviral Vector-Based Gene Therapy Products
- URL: https://www.fdaweb.com/draft-guide-on-retroviral-vector-based-gene-therapy-products/
- Published: 2018-07-13T12:00:00.000Z
- Updated: 2026-09-15T00:19:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141860

*Federal Register* notice: FDA has made available a draft guidance entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up.” The document provides recommendations regarding the testing for replication competent retrovirus (RCR) during the manufacture of such products, and during follow-up monitoring of patients who have received them. Recommendations include the identification and amount of material to be tested, and general testing methods. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-07-12/pdf/2018-14868.pdf?ref=fdaweb.com).