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Almac Diagnostics Attends Pre-IDE Meeting With FDA For Colorectal Cancer Diagnostic
Colorectal Cancer Almac Diagnostics had a preliminary Investigation Device Exemptoin (pre-IDE) meeting with the Food and Drug Administration (FDA) to discuss the proposed regulatory pathway for the company's prognostic gene signature for relapse in colorectal cancer (CRC). Senior company officials met with representatives of FDA's Center for Devices and Radiologic Health (CDRH) on April 13, 2007. [click link for full article]
