Guidance for Industry: Supplemental Guidance on Testing for Replication-Competent Retrovirus in Retroviral Vector-Based Gene Therapy Products and During Follow-Up of Patients in Clinical Trials Using Retroviral Vectors
Center for Biologics Evaluation and Research [CBER] (United States)
Human Gene Therapy 2001 February 10; 12(3): 315-320
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Guidance for Industry: Gene Therapy Clinical Trials -- Observing Participants for Delayed Adverse Events: Draft Guidance Center for Biologics Evaluation and Research [CBER] (United States) (2005-08)