A Regulatory Perspective on the Evaluation Companion Diagnostic Devices for Targeting Therapy
*Thomas E Gwise, Center for Devices and Radiological Health, FDA Keywords: Biomarker, Diagnostic, Device Personalized medicine promises treatments targeted to individual patients based on some individual characteristics, such as genomic or proteomic information. The characteristic or biomarker which defines the indicated population is often identified using a medical diagnostic device. Designing clinical trials that thoroughly evaluate both the treatment and the diagnostic test can be challenging. This presentation will discuss some of the challenges FDA statisticians face in reviewing diagnostic tests for personalized medicine applications.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC