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For Industry
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Transcript, Prescription Drug User Fee Act (PDUFA) Public Meeting November 14, 2005
Prescription Drug User Fee Act Public Workshop
Natcher Conference Center
National Institutes of Health
Building 45
Center Drive
Bethesda, Maryland
Monday, November 14, 2005
8:00 a.m.
P A R T I C I P A N T S
Ernest R. Berndt, Ph.D.
Bruce Burlington, M.D.
Judith A. Cahill
Perry Cohen, Ph.D.
Diane Edquist Dorman
Carole Redding Flamm, M.D., M.P.H.
RADM Steven Galson, M.D.
Jesse J. Goodman, M.D., M.P.H.
Scott Gottlieb, M.D.
Mary Gustafson, M.P.H.
Deborah Henderson, R.N., M.S.N.
Jeanne Ireland
Kenneth I. Kaitin, Ph.D.
Alison Lawton
Arthur A. Levin, M.P.H.
Alison Rein, M.S.
Ellen V. Sigal, Ph.D.
Hugh H. Tilson, M.D., Dr.P.H.
Allen J. Vaida, Pharm.D.
Bill Vaughan
Andrew C. von Eschenbach, M.D.
Susan C. Winckler, R.Ph., Esq.
Janet Woodcock, M.D.
Raymond L. Woosley, M.D., Ph.D.
William A. Zellmer, M.P.H.
Diana Zuckerman, Ph.D.
Bruce Burlington, M.D.
Judith A. Cahill
Perry Cohen, Ph.D.
Diane Edquist Dorman
Carole Redding Flamm, M.D., M.P.H.
RADM Steven Galson, M.D.
Jesse J. Goodman, M.D., M.P.H.
Scott Gottlieb, M.D.
Mary Gustafson, M.P.H.
Deborah Henderson, R.N., M.S.N.
Jeanne Ireland
Kenneth I. Kaitin, Ph.D.
Alison Lawton
Arthur A. Levin, M.P.H.
Alison Rein, M.S.
Ellen V. Sigal, Ph.D.
Hugh H. Tilson, M.D., Dr.P.H.
Allen J. Vaida, Pharm.D.
Bill Vaughan
Andrew C. von Eschenbach, M.D.
Susan C. Winckler, R.Ph., Esq.
Janet Woodcock, M.D.
Raymond L. Woosley, M.D., Ph.D.
William A. Zellmer, M.P.H.
Diana Zuckerman, Ph.D.
CONTENTS
Welcome
Deborah Henderson, Moderator
Opening Remarks
Andrew von Eschenbach, M.D.
Panel I - Presentations by FDA
Scott Gottlieb, M.D.
Janet Woodcock, M.D.
Steven Galson, M.D., M.P.H.
Jesse Goodman, M.D.
Janet Woodcock, M.D.
Steven Galson, M.D., M.P.H.
Jesse Goodman, M.D.
Panel II - Presentations by Academic Research Groups
Kenneth Kaitin, Ph.D.
Raymond L. Woosley, M.D., Ph.D.
Ernst R. Berndt, Ph.D.
Hugh Tilson, M.D.
Raymond L. Woosley, M.D., Ph.D.
Ernst R. Berndt, Ph.D.
Hugh Tilson, M.D.
Panel III - Presentations by Patient Advocacy Groups
Ellen V. Sigal, Ph.D.
Perry Cohen, Ph.D.
Diane Dorman
Jeanne Ireland
Perry Cohen, Ph.D.
Diane Dorman
Jeanne Ireland
Panel IV - Presentations by Consumer Groups
William Vaughan
Alison Rein, M.S.
Arthur Levin, M.P.H.
Diana Zuckerman, Ph.D.
Alison Rein, M.S.
Arthur Levin, M.P.H.
Diana Zuckerman, Ph.D.
Panel V - Presentations by Industry Groups
Alison Lawton
Bruce Burlington, M.D.
Mary Gustafson, M.P.H.
Bruce Burlington, M.D.
Mary Gustafson, M.P.H.
Panel VI - Presentations by Health Professional Groups
Carole Redding Flamm, M.D., M.P.H.
Judith A. Cahill
Susan Winckler, RPh., Esq.
Allen Vaida, Pharm.D.
William A. Zellmer, M.P.H.
Judith A. Cahill
Susan Winckler, RPh., Esq.
Allen Vaida, Pharm.D.
William A. Zellmer, M.P.H.
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