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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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Who's Who in Vioxx Safety - The FDA's List of Committee Participants

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 of navigation to provide you with the best possible Vioxx information. To contact a Vioxx Lawyer, click here for a FREE case evaluation.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH JOINT MEETING OF THE ARTHRITIS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
VOLUME I
Wednesday, February 16, 2005, 8:00 a.m
Hilton Gaithersburg
620 Perry Parkway
Gaithersburg, Maryland

PARTICIPANTS:
Alastair J.J. Wood, M.D., Chair

Arthritis Advisory Committee:

Allan Gibofsky, M.D., J.D.
Joan M. Bathon, M.D.
Dennis W. Boulware, M.D.
John J. Cush, M.D.
Gary Stuart Hoffman, M.D.
Norman T. Ilowite, M.D.
Susan M. Manzi, M.D., M.P.H.

Drug Safety and Risk Management Advisory Committee:

Peter A. Gross, M.D.
Stephanie Y. Crawford, Ph.D., M.P.H.
Ruth S. Day, Ph.D.
Curt D. Furberg, M.D., Ph.D.
Jacqueline S. Gardner, Ph.D., M.P.H.
Eric S. Holmboe, M.D.
Arthur A. Levin, M.P.H., Consumer Representative
Louis A. Morris, Ph.D.
Richard Platt, M.D., M.Sc.
Robyn S. Shapiro, J.D.
Annette Stemhagen, Dr.PH. Industry Representative

FDA Consultants (Voting):

Steven Abramson, M.D.
Ralph B. D'Agostino, Ph.D.
Robert H. Dworkin, Ph.D.
Janet Elashoff, Ph.D.
John T. Farrar, M.D.
Leona M. Malone, L.C.S.W., Patient Representative
Thomas Fleming, Ph.D.
Charles H. Hennekens, M.D.
Steven Nissen, M.D.
Emil Paganini, M.D., FACP, FRCP
Steven L. Shafer, M.D.
Alastair J.J. Wood, M.D., Chair

National Institutes of Health Participants (Voting):

Richard O. Cannon, III, M.D.
Michael J. Domanski, M.D.
Lawrence Friedman, M.D.

FDA Consultants (Non-Voting):

Byron Cryer, M.D. (Speaker and Discussant)
Milton Packer, M.D. (Speaker only)

Guest Speakers (Non-Voting):

Garret A. FitzGerald, M.D.
Ernest Hawk, M.D., M.P.H.
Bernard Levin, M.D.
Constantine Lyketsos, M.D., M.H.S.

FDA Participants:

Jonca Bull, M.D.
David Graham, M.D., M.P.H.
Brian Harvey, M.D.
Sharon Hertz, M.D.
John Jenkins, M.D., F.C.C.P.
Sandy Kweder, M.D.
Robert O'Neill, Ph.D.
Joel Schiffenbauer, M.D.
Paul Seligman, M.D.
Robert Temple, M.D.
Anne Trontell, M.D., M.P.H.
Lourdes Villalba, M.D.
James Witter, M.D., Ph.D.
Steven Galson, M.D.
Kimberly Littleton Topper, M.S., Executive Secretary

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see also:

Sponsor: Vioxx Vioxx Side Effects - Vioxx Lawyer - FDA Transcript - Sponsor: Vioxx (Rofecoxib)
Your Vioxx side effects lawyer provides the complete transcript of the FDA meeting.

Q & A Your Vioxx Lawyer - Vioxx, Celebrex & Bextra FDA Transcript - Q&A
Your Vioxx lawyer provides the complete transcript of the FDA meeting.

FDA Transcript - Day 1 Conference for Safety - Vioxx, Celebrex & Bextra FDA Transcript
Read here for the complete transcript of the FDA meeting for Vioxx

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