National Institute of Health / Laboratory Developed Tests Moderator / Institute of Medicine / /
IndustryTerm
healthcare system / manufacturing practices / Conventional medical device / treatment for breast cancer / manufacturing / healthcare providers / healthcare facilities / /
MedicalCondition
cancers / rare diseases / Cancer / disease / autism / given disease / heart disease / patient's disease / diseases / breast cancer / /
Organization
FDA's office of Media Affairs / Congress / National Institute of Health / CMS / Institute of Medicine / FDA's Center for Devices and Radiological Health / FDA / Department of Energy / /
Person
Jeffrey Shuren / Stephanie Yao / Katie Serrano / Liz Mansfield / Margaret Hamburg / Jeff Shuren / /
Position
Health and Human Services Secretary / Director / Commissioner / Noon EDT Coordinator / /
Product
moderate risk tests / exposure / LDTs / test results / high risk / diagnosis / /
Technology
genomics / diagnostic tests / drug development / in vitro diagnostics / /
Page 1 FDA Media Call on Companion Diagnostic Final Guidance and Proposed Risk-Based Oversight Framework for Laboratory Developed Tests Moderator: Stephanie Yao July 31, 2014