Evaluation of Orphan Products by the U.S. Food and Drug Administration
Haffner, Marlene E.
Kelsey, John V.
INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE1992 Fall; 8(4): 647-657
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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)