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
Human Gene Therapy 1998 July 1; 9(10): 1513-1524
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Unknown author (United States. Food and Drug Administration. Center for Biologics Evaluation and Research, 1998-07-01)
Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products. Notice of the Food and Drug Administration. Dated 24 September 1993 United States [law, statutes, etc.] (1994)