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FDA Transcript - Day 1

in this section: Participants | Call to Order | Conflict of Interest | Welcome | Regulatory History | GI Effects of NSAIDs | Cardio Events & COX-2 | Questions | Sponsor: Vioxx | Afternoon Proceedings | FDA: Vioxx | Q & A | Sponsor: Celebrex | Cardio Risk: Celecoxib | COX-2 Safety-Celecoxib | NIH: Celecoxib ACP Trial | NIH: PreSAP Trial | Answers | Valdecoxib and Parecoxib | Concluding Comments | Valdecoxib and Naproxen | Bayer/Roche: Naproxen | Naproxen Safety Data | Q & A


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What You Should Know - Transcript From the FDA Meeting on Pain Med Vioxx

Your Vioxx lawyer provides you the complete transcript of the February 16th, 2005 joint meeting of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. We have formatted the complete transcript of the three day conference for easy navigation to provide you with the best possible Vioxx information. To contact a Vioxx Lawyer, click here for a FREE case evaluation.

Contents:

Call to Order:
Alastair J. Wood, M.D., Chair

Conflict of Interest Statement:
Kimberly Littleton Topper, M.S.,

Welcome:
Steven Galson, M.D., MPH

Regulatory History
Jonca Bull, M.D.

Gastrointestinal Effects of NSAIDs and COX-2 Specific Inhibitors
Byron Cryer, M.D.,

Mechanism Based Adverse Cardiovascular Events and Specific Inhibitors of COX-2
Garret FitzGerald,

Committe Questions to Speakers

Sponsor Presentation: Vioxx (Rofecoxib),
Peter S. Kim, M.D.
Ned S. Braunstein, M.D.

AFTERNOON PROCEEDINGS

FDA Presentation: Vioxx (Rofecoxib),
Lourdes Villalba, M.D.,

Committee Questions to the Speakers

Sponsor Presentation: Celebrex (Celecoxib),
Joseph M. Feczko, M.D.

Cardiac Safety and Risk/Benefit Assessment of Celecoxib
Kenneth M. Verburg, Ph.D.

FDA Presentation: COX-2 CV Safety: Celecoxib,
James Witter, M.D., Ph.D.,

NIH and Investigator Presentation: Celecoxib in Adenoma Prevention Trials: The APC Trial (Prevention of Sporadic Colorectal Adenomas with Celecoxib)
Ernest Hawk, M.D.

NIH Investigator Presentation: The PreSAP Trial (Prevention of Colorectal Sporadic Adenomatous Polyps)
Bernard Levin, M.D.

Committee Questions to Speakers

Sponsor Presentation: Cardiovascular Safety and Risk/Benefit Assessment of Valdecoxib and Parecoxib
Kenneth M. Verburg, Ph.D.

Concluding Comments
Joseph M. Feczko, M.D.

FDA Presentation: COX-2 CV Safety: Valdecoxib-Parecoxib,
James Witter, M.D., Ph.D.

Bayer and Roche Joint Presentation on Naproxen,
Leonard M. Baum, R.Ph.

Safety Data
Martin H. Huber, M.D.

Committee Questions to Speakers



If you or a loved one has been injured by a cox-2 specific inhibitor such as Bextra, Celebrex or Vioxx, please fill out our FREE case evaluation form. A Client Relations Representative will contact you shortly to discuss your potential case. Feel free as well to call us at (800) 476-6070 or email us at clientrelations@weitzlux.com


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see also:

Cardio Events & COX-2 Your Vioxx Lawyer - Vioxx, Celebrex & Bextra FDA Transcript - Cardiovascular Events, COX-2
Your Vioxx lawyer provides the complete transcript of the FDA meeting.

Bayer/Roche: Naproxen Your Vioxx Lawyer - Vioxx, Celebrex & Bextra FDA Transcript - Bayer, Roche: Naproxen
Your Vioxx lawyer provides the complete transcript of the FDA meeting.

More Merck Losses Merck Insurance Carriers Jump Ship Over Vioxx Losses
Merck Insurance Carriers Jump Ship Over Vioxx Defense Costs & Losses

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