Bioequivalence Articles
FDA plans workshop with Professional endocrine societies
FDA Bioequivalence Workshop Plans continue with ATA, Endocrine Society and AACE leaders 2003-2004 President Clark T. Sawin, M.D. Washington, D.C. Secretary Gregory A. Brent, M.D. Los Angeles, California Treasurer Charles H. Emerson, M.D. Worcester, Massachusetts President-Elect Paul W. Ladenson, M.D. Baltimore, Maryland Directors Peter A. Singer, M.D. Los Angeles, California Jeffrey R. Garber, M.D. Boston, Massachusetts Stephanie L. Lee, M.D., Ph.D. Boston, Massachusetts John C. [...]
…Read moreAgenda for levothyroxine workshop
Draft Levothyroxine Workshop Agenda Download Agenda (PDF File, 108 KB) See related articles on Bioequivalence of Levothyroxine
…Read moreFDA invites Professional endocrine societies to thyroxine bioequivalence workshop
FDA invites ATA, TES & AACE to Plan Workshop on Thyroxine Bioequivalence # # # See related articles on Bioequivalence of Levothyroxine
…Read moreATA continues dialog with FDA on dose precision
ATA Continues Dialog With FDA on Levothyroxine Dose Precision and Bioequivalence Standards 2003-2004 President Clark T. Sawin, M.D. Washington, D.C. Secretary Gregory A. Brent, M.D. Los Angeles, California Treasurer Charles H. Emerson, M.D. Worcester, Massachusetts President-Elect Paul W. Ladenson, M.D. Baltimore, Maryland Directors Peter A. Singer, M.D. Los Angeles, California Jeffrey R. Garber, M.D. Boston, Massachusetts Stephanie L. Lee, M.D., Ph.D. Boston, Massachusetts John C. [...]
…Read moreATA asks FDA to ensure safety and effectiveness of levothyroxine preparations
ATA asks the FDA to ensure safe and effective levothyroxine preparations April 4, 2003 Mark McClellan, M.D., Ph.D.Commissioner U.S. Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 Dear Dr. McClellan: The undersigned, representing the more than 10,000 members of our respective societies, are writing to express our concern with the current FDA Guidance for assessing bioequivalence of levothyroxine (T4) products. Several of our [...]
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