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Food and Drug Administration

Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Advisory Committees for Pharmaceutical Science

October 4, 2006

Slides

FDA Presentations

Introduction to Joint Advisory Committee Meeting on Levothyroxine Sodium Products, Mary H. Parks, M.D., FDA (pdf)

Regulatory History of Levothyroxine Products, Jane A. Axelrad, J.D., FDA (pdf)

Clinical Perspectives on Levothyroxine Products, Mary H. Parks, M.D., FDA (pdf)

Stability of Levothyroxine Sodium Products, Eric Duffy, Ph.D., FDA (pdf)

Industry Presentations

Global Experience: Levothyroxine Quality and Safety, Bonnie Southorn, Ph.D., Genpharm Inc. (pdf)

Mylan’s Unique Formulation and Process for the Consistent Production of a Potent, Uniform and Stable Levothyroxine Sodium Product, David Wargo, R.Ph., Ph.D., Mylan Pharmaceuticals, Inc. (pdf)

Open Public Hearing Speakers

Leonard Wartofsky, M.D., The Endocrine Society (pdf)

Jeffrey R.Garber, M.D., American Association of Clinical Endocrinologists (pdf)

James V. Hennessey, M.D., American Thyroid Association (pdf)

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Page last updated October 13, 2006 kkhorizonal rule
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