Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy -- March 1998
Human Gene Therapy. 1998 Jul 1; 9(10): 1513-1524.
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Regulatory Issues: Guidance for Industry -- Guidance for Human Somatic Cell Therapy and Gene Therapy: March 1998 United States. Food and Drug Administration. Center for Biologics Evaluation and Research (1998-07-01)