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
Correspondence listed below.
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)