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FDA Biological Response Modifiers Advisory Committee

Executive Summary

Agency's newest advisory committee will hold its first meeting July 30-31. The panel was formed to help with FDA reviews of cytokines and other biologicals seeking approval for use in treating cancer. The meeting's agenda has not been released, but reportedly, the committee's first reviews could involve GM-CSF and G-CSF. PLAs for GM-CSF products were filed earlier this year by Immunex and Schering-Plough. Amgen submitted a PLA for G-CSF in December.
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