Food and Drug Administration
February 16, 2005
Slides
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)