Medical Devices
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Correspondence related to Duke University Prospective Study Evaluating the Role of Pemetrexed Plus Gemcitabine Chemotherapy for Chemo-naïve Select Stage IIB and IV Non-Small Cell Lung Cancer (NSCLC) in Patients Using a Genome Predictor of Platinum-Resistance to Guide Therapy
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Letter to Division of Medical Oncology, Duke University Medical Center (PDF - 89KB)Letter to FDA's CDER from Division of Medical Oncology, Duke University Medical Center (PDF - 350KB)
Note: CDER has no record of receiving Dec. 2009 letter from Dr. Anil Potti discussing an IND-exemption for the trial that received pre-IDE review. The letter was brought to FDA’s attention during our inspection of the Duke IRB and clinical investigators.FDA Establishment Inspection Report, Duke University Medical Center, January 2011 (PDF - 3.3MB)
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