Regulatory considerations for novel gene therapy products: a review of the process leading to the first clinical lentiviral vector
Humeau, Laurent M.
Binder, Gwendolyn K.
Levine, Bruce L.
MacGregor, Rob- Roy
June, Carl H.
Human Gene Therapy 2005 January; 16(1): 17-25
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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) (2001-02-10)