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: Dec. 20 meeting in Rockville, Maryland is canceled "at the request of the sponsor of the application," FDA says. The panel was slated to review a premarket application for a device that "calculates a composite index from currently available serum-based clinical laboratory tests to provide additional information" to identify osteopenia in women. The application will be considered at a future panel meeting. For more information contact Cornelia Rooks at 310/594-1243...
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