Correspondence listed below.
- Letter to Division of Medical Oncology, Duke University Medical Center - University Medical Center regarding Phase II Prospective Study Evaluating the Role of Pemetrexed Plus Gemcitabine Chemotherapy.
- Letter to FDA's CDER from Division of Medical Oncology, Duke University Medical Center - 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 - FDA Establishment Inspection Report for Duke University Medical Center, January 31, 2011.