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U.S. Department of Health and Human Services

Advisory Committees

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Slides for the August 4, 2009 Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee

FDA PRESENTATIONS

 

Topic Introduction (pdf)

Robert A. Lionberger, Ph.D.

Chemist, Office of Generic Drugs (OGD), OPS, CDER, FDA

 

Update on the Changing Epidemiology of Clostridium difficile Infections (pdf)

LawrenceC. McDonald, M.D.

Centers for Disease Control, Atlanta, Georgia

 

Bioequivalence: The Critical Role of Dissolution (pdf)

Gordon L. Amidon, Ph.D.

Professor of Pharmacy and Professor of Pharmaceutical Science, the University of Michigan

 

FDA Recommendation for Vancomyci HCl Capsule BE Studies (pdf)

Barbara M. Davit, Ph.D., J.D.

Acting Director, Division of Bioequivalence 2

(DBE 2), OGD, OPS, CDER, FDA

 

 

INDUSTRY PRESENTATIONS

 

ViroPharma Incorporated (pdf)

 

Generic Industry Positions (pdf)

(Akorn, Inc., Impax Laboratories, Inc., Mylan Pharmaceuticals Inc.,

Paddock Laboratories, Inc., Sandoz Inc., Strides Arcolab Limited,

Teva Pharmaceuticals USA, Watson Pharmaceuticals, Inc)

 

Presentation by:

Scientific Perspective

Russell J. Rackley, Ph.D. (pdf)

Vice President, Pharmacokinetics/Drug Metabolism,

Mylan Pharmaceuticals Inc.

 

Clinical Pharmacy Perspective

Douglas Slain, Pharm.D., BCPS, FCCP

Associate Professor, West Virginia University

 

Medical Perspective

Dale L. Coy, M.D., FACG

Division of Gastroenterology

Advocate Healthcare System, Chicago, IL

 

 

Open Public Hearing

 

OPH 1: (pdf)