FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Cardiovascular and Renal Drugs Advisory Committee

Holiday Inn Gaithersburg

Two Montgomery Village Avenue, Gaithersburg, MD

Slides

June 15, 2005

The committee will discuss class labeling of antihypertensive drugs based on the proximity of their data to outcome trials

Applicable Outcomes Claims Stephen W. MacMahon, B.Sc., Ph.D., M.P.H., F.A.C.C.

For Antihypertensive Drugs Principal Director

[HTML] [PPT] Professor of Cardiovascular Medicine and Epidemiology

The George Institute for International Health

The University of Sydney

Differences in Outcomes Claims Stephen W. MacMahon, B.Sc., Ph.D., M.P.H., F.A.C.C.

For Different Drug Classes

[HTML] [PPT]

Deciding Whom to Treat Jay N. Cohn, M.D.

For Hypertension Professor of Medicine and Director

[HTML] [PPT] Rasmussen Center for Cardiovascular Disease Prevention

University of Minnesota

When to Initiate Successive Henry R. Black, M.D.

Antihypertensive Drugs Chairman and Associate Vice President for Research

[HTML] [PPT] Rush University Medical Center

Can One Sustain an Outcome

Claim Based on an Active

Controlled Study?

Introduction Lance Berman, MD

Medical Director – U.S. Team Leader

Pfizer, Inc.

Methodology and Analysis Michael Gaffney, Ph.D.

[Overview] Senior Director – Statistical Research and Consulting

[HTML] [PPT] . Pfizer, Inc

Does the Pattern of Blood Thomas G. Pickering, M.D., Ph.D., F.R.C.P.

Pressure Effects During the Director – Integrative and Behavioral Cardiology Program

Day Matter? The Zena and Michael A. Wiener Cardiovascular Institute

[HTML] [PPT] Mount Sinai Medical Center

Does the Benefit Associated with Ronald J. Portman, M.D.

Treating Hypertension Apply to Professor of Pediatrics and Director of the Division

Children? Pediatric Nephrology and Hypertension

[HTML] [PPT] University of Texas – Houston Medical School

[HTML] [PPT] Open Public Hearing Speakers

[HTML] [PPT] Questions