Food and Drug Administration - FDA

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Sep 12, 2007 - Metropolitan Park East, Suite 1360. Seattle, Washington 98101-1448 ... Salt Lake City, Utah 84112. Encino, California 91316. Stephanie Y.
Food and Drug Administration Center for Drug Evaluation and Research Joint Meeting of the Cardiovascular and Renal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee September 12, 2007 Meeting Roster Cardiovascular and Renal Drugs Advisory Committee Members (voting) Steven D. Findlay, M.P.H. (Consumer Representative) 1666 Connecticut Avenue, Suite 310 Washington, District of Columbia 20009

Emil P. Paganini, M.D. The Cleveland Clinic Foundation 9500 Euclid Avenue M-82 Acute Nephrology Service Cleveland, Ohio 44195

Robert A. Harrington, M.D., F.A.C.C. (Acting Chair) Duke University Medical School Duke Clinical Research Institute 2400 Pratt Street, NP 7007 Room 0311, Terrace Level Durham, North Carolina 27705

John R. Teerlink, M.D. University of California, San Francisco San Francisco Veteran's Affairs Medical Center 111C 4150 Clement Street San Francisco, California 94121 Lynn Warner-Stevenson, M.D. Brigham and Women’s Hospital Cardiovascular Division 75 Francis Street Boston, MA 02115

Frederick J. Kaskel, M.D., Ph.D. Children’s Hospital at Montefiore Albert Einstein College of Medicine of Yeshiva University 111 East 210 Street Bronx, NY 10467 Michael A. Lincoff, M.D. The Cleveland Clinic Foundation Desk F25, 9500 Euclid Avenue Cleveland, Ohio 44195

Drug Safety and Risk Management Drugs Advisory Committee Members (voting) Susan R. Heckbert, M.D., Ph.D. University of Washington Cardiovascular Health Research Unit 1730 Minor Avenue Metropolitan Park East, Suite 1360 Seattle, Washington 98101-1448

Timothy S. Lesar, Pharm.D. Albany Medical Center 43 New Scotland Avenue Albany, New York 12208

Judith M. Kramer, M.D., M.S. Duke University Medical Center 2400 Pratt Street, Room 0311 Terrace Level North Pavilion, Room 7024 Durham, North Carolina 27705

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Food and Drug Administration Center for Drug Evaluation and Research Joint Meeting of the Cardiovascular and Renal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee September 12, 2007 Meeting Roster (cont.) Temporary Voting Members Jeffrey R. Balser, M.D., Ph.D. Vice-Chancellor's Office D3300 Medical Center North Nashville, Tennessee 37232-2104 Henry R. Black, M.D. New York University School of Medicine 550 First Avenue New York, New York 10016

James W. Gillett, Ph.D. (Patient Representative) 150 Burdick Hill Road Ithaca, New York 14850-8527 Valluvan Jeevanandam, M.D. University of Chicago Hospitals 5841 S. Maryland Avenue, MC 5040 Chicago, Illinois 60637

Alfred Cheung, M.D. University of Utah-Dialysis Program 85 North Medical Drive East, Room 201 Salt Lake City, Utah 84112

Norman S. Kato, M.D., F.A.C.C Cardiac Care Medical Group, Inc. 5535 Balboa Boulevard, Suite 112 Encino, California 91316

Stephanie Y. Crawford, Ph.D. University of Illinois at Chicago 833 S. Wood Street, M/C 871 Chicago, Illinois 60612

James D. Neaton, Ph.D. University of Minnesota School of Public Health 2221 University Avenue SE, Suite 200 Minneapolis, Minnesota 55414

Ruth S. Day, Ph.D. Duke University Box 90085 Durham, North Carolina 27708

Lewis S. Nelson, M.D. NYC PCC 455 First Avenue, Room 123 New York, New York 10016

John E. Ellis, M.D. The University of Chicago 5841 South Maryland Avenue, MC 4028 Chicago, Illinois 60637

Industry Representative (non-voting) Annette Stemhagen, D.Ph. United BioSource Corporation 920 Harvest Drive, Suite 200 Blue Bell, Pennsylvania 19422

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Food and Drug Administration Center for Drug Evaluation and Research Joint Meeting of the Cardiovascular and Renal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee September 12, 2007 Meeting Roster (cont.) Guest Speakers (non-voting): Paul Corso, M.D. Washington Hospital Center 110 Irving Street, Suite 1E3 Washington, District of Columbia 20010

Dennis T. Mangano, Ph.D., M.D. Ischemia Research and Education Foundation 1111 Bayhill Drive, Suite 480 San Bruno, California 94066

Keyvan Karkouti, M.Sc., M.D., F.R.C.P.C. Toronto General Hospital 200 Elizabeth Street, 3rd Floor Rm 402 Toronto, Ontario Canada M5G2C4

************************************************************************ FDA Participants at the Table (non-voting) John Jenkins, M.D. Director, Office of New Drugs (OND) CDER, FDA

Richard Pazdur, M.D. Director Office of Oncology Drug Products (OODP), CDER, FDA

Mark Levenson, M.S Office of Translational Sciences (OTS), Office of Biostatistics (OB), Division of Biometrics VI (DBVI), CDER, FDA

Rafel Dwaine Rieves, M.D. Acting Director, Division of Medical Imaging and Hematology Products (DMIHP), CDER, FDA George Shashaty, M.D. Medical Officer, OODP, CDER, FDA

Gerald Dal Pan, M.D. Director, Office of Surveillance and Epidemiology, CDER, FDA

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