Moving Assays to The Clinic

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Next Generation Dx Summit 2009
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Enabling Point-of-Care Diagnostics

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Clinical Adoption of Next Generation Diagnostics

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PLENARY KEYNOTE SESSION

GAINING REGULATORY APPROVAL FOR MOLECULAR DIAGNOSTIC TESTS

Alberto Gutierrez

 

Alberto Gutierrez, Ph.D., Deputy Director of OIVD, Office of in Vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration

 

 

Elliot Cowan

 

Elliot Cowan, Ph.D., Chief, Product Review Branch, Division of Emerging and Transfusion Transmitted Diseases, FDA/CBER/OBRR

 

 

 

PRE-CONFERENCE SYMPOSIA

(SC1) CIRCULATING TUMOR CELLS AS SURROGATE ENDPOINTS IN CLINICAL TRIALS

(SC2) REALITY CHECK ON COMPANION DIAGNOSTICS

 
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