lunes, 11 de abril de 2016

CDRH Industry: An FDA-AACR Public Workshop – Liquid Biopsies in Oncology Drug and Device Development, July 19, 2016

The Food and Drug Administration (FDA) and Co-sponsor American Association for Cancer Research (AACR) are announcing a public workshop, Liquid Biopsies in Oncology Drug and Device Development scheduled for July 19, 2016.  The workshop will provide a forum to discuss relevant scientific advances in the field of liquid biopsies in oncology and a regulatory environment that will support rapid translation of this emerging technology into improved patient care.
The workshop aims to: 1) provide a state of the science overview of liquid biopsies in oncology; 2) discuss the use of tumor-derived cfDNA in drug development and clinical use, focusing on the treatment of lung cancer as a case study; 3) discuss current approaches to validation of in vitro diagnostic devices (or tests); and 4) discuss with diverse stakeholders ways to accelerate development of these technologies to advance cancer care.

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