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In Brief: FDA Biological Response Modifiers Committee

This article was originally published in The Gray Sheet

Executive Summary

FDA Biological Response Modifiers Committee: Slated to meet Feb. 28 and 29 at the Holiday Inn in Bethesda, Maryland. On Feb. 28 the committee will discuss a premarket approval application for CellPro's Ceprate SC device for selection of CD34+ progenitor/stem cells and receive an update on "stem cell policy," according to a Jan. 31 notice in the Federal Register. On Feb. 29 the committee will discuss issues in early clinical trial development for in utero stem cell transplantation and the draft addendum to the 1991 points-to-consider on human somatic cell and gene therapy. Contact FDA's William Freas or Pearline Muckelvgene, 301/827-0314...

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