FDA/AUA Prostate Cancer Workshop: Clinical Trial Design Issues: Drug and Device Development for Localized Prostate Cancer
Sunday, May 5, 2013
Manchester Grand Hyatt, San Diego – Douglas Pavilion C&D

Introduction
Jonathan P. Jarow, MD

Regulatory Basis of Drug Approval & Qualification of Biomarkers
Paul Kluetz

Regulatory Basis of Device Approval
John H. Baxley, MD, PhD

Development of Patient Reported Outcomes Instruments
Raymond Rosen, MD

Clarifying Questions
Panel Discussion
Panel Discussion
Panel Discussion
Panel Discussion

Transcripts of FDA-AUA Prostate Cancer Workshop
May 5, 2013
May 5, 2013 – condensed

 

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AUA2013 Meeting Location:
San Diego Convention Center – 111 W. Harbor Drive, San Diego, CA 92101