Food and Drug Administration
October 9, 2003
Slides
Overview of FDA Regulatory Issues, Dr. Darin Weber, PhD, FDA (HTM) (PPT)
HRSA's Role in Pancreas and Islet Transplantation, Dr. Jim Burdick, MD, HRSA (HTM) (PPT)
Expectations for Facilities & cGMPs, Dr. Nicholas Obiri, PhD, FDA (HTM) (PPT)
Processing and Product Quality Issues, Assessing the Final Product, Dr. Keith Wonnacott, PhD, FDA (HTM) (PPT)
Open Public Hearing
Islet Transplantation: Focus on Manufacturing, Dr. Michael Millis, MD, University of Chicago (HTM) (PPT)
Worldwide Islet Transplant Activity, 1999-2003, Dr. Goldstein (HTM) (PPT)
Islet Transplantation: A JDRF Success Story, Dr. Goldstein (HTM) (Word)