Food and Drug Administration

Arthritis Advisory Committee

March 5, 2003


Introduction, Dr. Lee Simon, MD (HTM) (PPT)

The Health Assessment Questionnaire (HAQ) and Drug Development & Approval, Dr. James Fries, MD, FDA (HTM) (PPT)


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.

ARAVA® (Leflunomide), Aventis Pharm. (HTM) (PPT)

Statistical Issues in the Analysis of 2-Year HAQ for ARAVA™, Dr. Suktae Choi, PhD, FDA (HTM) (PPT)

Hepatotoxicity: Leflunomide, Lawrence Goldkind, FDA (HTM) (PPT)

Rare a& Serious Events - Label Comprehension, Ruth Day, FDA (HTM) (PPT)