FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
horizonal rule
Dockets Management

Up | AC Home Page

Food and Drug Administration

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

October 4, 2006


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)

Up | AC Home Page

Page last updated October 13, 2006 kkhorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management