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Human somatic cell/gene therapy "points to consider

Executive Summary

Draft is available, FDA announces in Nov. 29 Federal Register. Topics reviewed in the draft, which is dated August 1991, include characterization of cell populations, preclinical safety testing, lot-to-lot manufacturing, control testing and clinical trial considerations. Requests for the document may be addressed to: Congressional, Consumer, and International Affairs Branch (HFB-142), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Enclose two self-addressed adhesive labels. . . .

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