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Draft Guide on Retroviral Vector-Based Gene Therapy Products
07/13/2018
 

Federal Register notice: FDA has made available a draft guidance entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up.”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.


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