Wednesday, November 11, 2009

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Avandia Hearing Notes

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This Just In: Avandia stays on the market
In a 22-1 vote, a panel advising the FDA on the future of popular diabetes drug Avandia chose to keep the drug on the market.
Live from the Avandia Review: 7:30 a.m.
Judging by the hoopla in this Holiday Inn in Gaithersburg, Md., people have really been paying attention to all the recent controversy about Avandia.
Avandia Review: Tell Us Something We Don't Know!
An introduction to the growing problem of type 2 diabetes from the FDA panel's Avandia review.

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Avandia Review: GlaxoSmithKline takes the stage
Read GlaxoSmithKline's (GSK) response to the accusations that Avandia causes severe side effects for cardiovascular health.
Avandia Hearing Agenda
Avandia hearing presentation: Robert E. Ratner, MD
Achieving Diabetes Targets: Where are we, and how can we do better?
Avandia hearing presentation: Joy Mele, statistician
FDA Meta-Analysis
Avandia hearing presentation: Karen Mahoney, MD
Overview of Large Prospective Trials of Thiazolidinediones: Study Design and Current Status of Cardiovascular Safety Data
Avandia Presentation by David Gordon, MD
Use of Rosiglitazone in the BARI 2D Trial
Avandia Presentation by Kate Gelperin, MD
Effect of Antidiabetic Agent Choice on Cardiovascular Morbidity and Mortality in Type 2 Diabetes Mellitus
Avandia Review Presentation: David Graham, MD
Assessment of the cardiovascular risks and health benefits of rosiglitazone.
List of Tentative Meeting Dates, Center for Drug Evaluation and Research
Accessing Advisory Committee Information
Editorial by Dr. Richard Hellman
The Perfect Storm -- Drug Safety and Rosiglitazone
Advisory committee mailbox codes

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