Food and Drug Administration
Arthritis Advisory Committee
March 5, 2003
Introduction, Dr. Lee Simon, MD (HTM)
The Health Assessment Questionnaire (HAQ) and Drug Development & Approval,
Dr. James Fries, MD, FDA (HTM)
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)
Statistical Issues in the Analysis of 2-Year HAQ for ARAVA™, Dr. Suktae
Choi, PhD, FDA (HTM) (PPT)
Hepatotoxicity: Leflunomide, Lawrence Goldkind, FDA (HTM)
Rare a& Serious Events - Label Comprehension, Ruth Day, FDA (HTM)