October 26

VIOXX WITHDRAWAL: FDA TO JOIN AUDIO CONFERENCE ON NOVEMBER 10

VIOXX WITHDRAWAL: FDA TO JOIN AUDIO CONFERENCE ON NOVEMBER 10

Mon, 8 Nov 2004

To hear from FDA Office of New Drugs Acting Director Sandra Kweder, MD, in an interactive discussion of what the withdrawal of the blockbuster drug means for the agencys drug safety programs, the COX-2 inhibitor class and the drug industry as a whole, costs "Only $395 for single-line (computer/phone) access; $795 for multiple lines at one organization. To register, or for more information, please visit www.drugdevicedialogue.com or call 800-332-2181."

This is how the FDA conducts discussions / dialogues about drug safety – by effectively keeping the public out!

Contact: Vera Hassner Sharav
212-595-8974

From: FDAAdvisoryCommittee.com
Sent: Monday, November 08, 2004 11:15 AM
To: veracare
Subject: VIOXX WITHDRAWAL: FDA TO JOIN AUDIO CONFERENCE ON NOVEMBER 10

Vioxx: What Went Right, What Went Wrong?
Wednesday, Nov. 10
3:00-4:30 EST
http://www.drugdevicedialogue.com

Hear from FDA Office of New Drugs Acting Director Sandra Kweder, MD, in an interactive discussion of what the withdrawal of the blockbuster drug means for the agencys drug safety programs, the COX-2 inhibitor class and the drug industry as a whole.

Lee Simon, MD, an Associate Professor at Harvard Medical School, and Peter Pitts, Director of Health Affairs for Manning, Selvage & Lee Global Health, will provide their perspectives on the research, marketing and advertising implications of the unprecedented Vioxx recall.

Get Authoritative Answers To Such Critical Questions As:

* How well did current regulatory policies work given the available data?

* Will the Vioxx withdrawal affect the way FDA balances its objectives of getting important new drugs to market and determining their adverse event profiles?

* How much drug safety information is enough, both before and after approval?

* Do the existing data implicate the safety of the COX-2 class of drugs?

* How effective was Merck’s crisis communication effort?

* Will DTC ad policies be affected by the withdrawal?

Register today!

Only $395 for single-line (computer/phone) access; $795 for multiple lines at one organization. To register, or for more information, please visit www.drugdevicedialogue.com or call 800-332-2181. Drug & Device Dialogue online symposiums feature high-quality audio presentations over the Internet or telephone, complemented by synchronized slide presentations, background materials and user-friendly Q&A.

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