Arthritis & Drug Safety and Risk Management

Advisory Committee Briefing Package

February 16, 17, and 18, 2005



Additional Briefing Information


2/9/05  Addendum to Food and Drug Administration Background Information


  1. New Document:   (WORD) (PDF) (HTML)

Preliminary Review of APPROVe data

To be included as 1st document under Tab H



  1. Replacement Document:  (WORD) (PDF) (HTML)

Preliminary review of GI and CV data from TARGET dated (1/18/05)

To replace 2nd document under Tab U