Guidance for Industry: Special Protocol Assessment
Rockville, MD: Center for Biologics Evaluation and Research, 2002 May; 10 p. [Online]. Available: http://www.fda.gov/cder/guidance/3764fnl.htm [2003 February 11]
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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)