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Reference 10 Briefing Document - Testing for Replication Competent Retrovirus…

Supporting & Related Material · FDA-1999-D-0081 · posted Jan 30, 2020

Key facts

Document ID FDA-1999-D-0081-0063
Title Reference 10 Briefing Document - Testing for Replication Competent Retrovirus RCR-Lentivirus RCL in Retroviral and Lentiviral Vector Based Gene Therapy Products re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry
Document type Supporting & Related Material
Subtype Background Material
Agency FDA
Docket FDA-1999-D-0081
Posted Jan 30, 2020

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