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Immunology Devices Panel meeting

This article was originally published in The Gray Sheet

Executive Summary

FDA advisory panel meeting August 19 in Rockville, Maryland to discuss draft guidances on anti-nuclear antibodies, anti-thyroid antibodies, and alpha-fetaprotein for neural tube defects. The panel will also discuss points-to-consider documents on "immunohistochemical antibody products and tumor markers (carcinoembryonic antigen, alphafetaprotein, and prostate specific antigen) for monitoring." The panel's agenda also includes open and closed discussion on "pending or future device applications." For more information, contact Peter Maxim at 301/594-1293



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