Food and Drug Administration

Biological Response Modifiers Advisory Committee

October 9, 2003


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)