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In Brief: Clinical Chemistry and Clinical Toxicology Devices Panel

This article was originally published in The Gray Sheet

Executive Summary

Clinical Chemistry and Clinical Toxicology Devices Panel: Meeting Dec. 10 at FDA's Corporate Building in Rockville, Maryland to provide the agency with a recommendation on Biex' premarket approval application for its SalEst test, which evaluates samples of salivary estriol to identify women at risk for preterm labor. The PMA includes data from a 956-patient, eight-center blinded study. For more information, contact FDA's Sharon Lappalainen at 301/594-1243, ext. 144...



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