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Gene therapy trials

Executive Summary

FDA's Biological Response Modifiers Advisory Committee will discuss long-term follow-up of patients in gene therapy clinical trials Oct. 24 at 9 a.m.. The committee rejected FDA's initial long-term follow-up proposal, a tiered system based on gene transfer vector, at its April 6 meeting (1"The Pink Sheet" April 16, p. 31). The committee will discuss vector design, manufacture and preclinical studies of lentivirus vectors in gene therapy trials Oct. 25, beginning at 8 a.m. On Oct. 26, committee members will discuss development of a lentivirus vector gene transfer product for people with HIV beginning at 8 a.m. The meeting will be held all three days at the Holiday Inn, Gaithersburg, Md

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