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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