Food and Drug Administration

Joint Meeting with the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee

February 16, 2005


Regulatory History, Dr. Jonca Bull, MD, FDA (HTM) (PPT)

Gastrointestinal Effects of NSAIDs and COX-2 Specific Inhibitors, Dr. Byron Cryer, MD, FDA (HTM) (PPT)

Mechanism Based Adverse Cardiovascular Events and Specific Inhibitors of COX-2, Dr. Garret FitzGerald MD, University of Pennsylvania (HTM) (PPT)

Assessing Risk/Benefit of Rofecoxib/COXIBs, Dr. Ned Braunstein, MD, Merck Research Labs (HTM) (PPT)

VIOXX, Cardiovascular Safety, Dr. Lourdes Villalba, MD, FDA (HTM) (PPT)

Cardiovascular Safety of Celecoxib & Risk-Benefit Assessment - Celebrex, Pfizer (HTM) (PPT)

Backup Celecoxib Slides, Pfizer (HTM) (PPT)

COX-2 CV Safety - Celecoxib, Dr. James Witter, MD, PhD (HTM) (PPT)

Celecoxib in Adenoma Prevention - The APC Trial, Dr. Ernest Hawk, MD, MPH, NIH (HTM) (PPT)

Celecoxib in Adenoma Prevention - The PreSAP Trial, Dr. Bernard Levin, MD FDA (HTM) (PPT)

Cardiovascular Safety of Valdecoxib and Parecoxib & Risk-Benefit Assessment, Pfizer (HTM) (PPT)

COX-2 CV Safety - valdecoxib-parecoxib, Dr. James Witter, MD, PhD, FDA (HTM) (PPT)

Presentation by Bayer HealthCare and Hoffman-LaRoche, Inc. - Naproxen (HTM) (PPT)