Healthy Skepticism Library item: 9412

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Publication type: report

US FDA
FDA Background Package for the Arthritis Advisory Committee Meeting, April 12, 2007
: US FDA 2007 Apr 12
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4290b1-01-FDA.pdf

Abstract:

This background package consists of the below-listed documents in the following order
Document #
General topic Description Reason included
1 Introduction Dr. Rappaport’s Memo to Advisory Committee Members
Introduction to purpose of meeting and issues to be considered.
2 February 2005 AAC Meeting Flash minutes from February 2005 Arthritis Advisory Committee Meeting
Brief description of issues discussed and voting on Agency questions from February 2005 AC Meeting.
3 February 2005 AAC Meeting AAC Meeting transcript-2/17/05
Merck presentation—pages 152-188
FDA presentation—pages 188-201
Panel Discussion—pages 347-387
4 Agency position on NSAIDs
FDA Decisional Memo, Drs. Jenkins and Seligman
Articulates Agency’s thinking regarding NSAIDs/COX-2 inhibitors in 2005
5 Agency position on NSAIDs
NSAID Package Insert template
Includes language required by FDA for NSAIDs following Decisional Memo
6 Agency position on NSAIDs
NSAID Medication Guide template
Includes language required by FDA for NSAIDs following Decisional Memo
7 FDA review of current submission
Expanded Executive Summary from Medical Officer’s review
Articulates Agency review of efficacy and safety data relevant to current submission
8 FDA review of current submission
Executive Summary from Statistician’s review
Describes Agency review of safety data
9 General Bibliography of referenced articles
Provides references for articles cited
10-14 General Citations for selected references
• Three journal articles regarding NSAIDs and GI toxicity including one description of the MEDAL data.
• Two editorials regarding the MEDAL Program.

Notes:

This meeting advised against the approval of Arcoxia (etoricoxib). Follow link for full package.