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...