Food and Drug Administration

Arthritis Advisory Committee

September 29, 2003


Welcome and Introduction, Dr. Lee Simon, MD, FDA (HTM) (PPT)

ACR SLE Response Criteria Initiatives, Dr. Matthew Liang, MD, MPH, et. al. (HTM) (PPT)

Objective Lab Measures, Dr. Jill Buyon, MD (HTM) (PPT)

Discussion of SLE Concept Paper State of the Art: HRQOL, Fatigue and Function, Dr. Vibeke Strand, MD, Stanford University (HTM) (PPT)

Childhood SSSLE In The 21st Century The State of the Art - How Do We Get The Best Possible Outcome, Dr. Thomas Lehman, MD, Cornell Univeristy Medical College (HTM) (PPT)

Claime Structure for SLE, Dr. Jeffrey Siegel, MD (HTM) (PPT)

Biomarkers and Subparts, Dr. James Witter, MD, PhD, FDA (HTM) (PPT)

Open Public Hearing


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

LymphoStat-B™ - A Case Study for Endpoints and Trial Design in SLE, Dr. Bill Freimuth, MD, PhD (HTM) (PPT)