Food and Drug Administration FDA Center for Drug Up

Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) with the Advisory Committee for Pharmaceutical Science (ACPS) October 4, 2006 Meeting Participants EMDAC Members in attendance (voting) Kenneth D. Burman, M.D. Thomas O. Carpenter, M.D. Jessica W. Henderson, Ph.D. Katherine M. Flegal, Ph.D. Michael Proschan, Ph.D. Clifford J. Rosen, M.D. Morris Schambelan, M.D. Nelson B. Watts, M.D. Margaret E. Wierman, M.D. EMDAC Member in attendance (non- voting) Steven W. Ryder, M.D. (Industry Representative) ACPS Members in attendance (voting) Charles L. Cooney, Ph.D. Carol Gloff, Ph.D. Meryl H. Karol, Ph.D. Melvin V. Koch, Ph.D. Kenneth R. Morris, Ph.D. ACPS Member in attendance (non-voting) Paul H. Fackler, Ph.D. (Industry Representative) Special Government Employee (SGE) Consultants (voting) Marvin C. Meyer, Ph.D. Adrian S. Dobs, M.D. Arthur H. Kibbe, Ph.D. William V. Tamborlane, M.D. Paul D. Woolf, M.D Lynne Levitsky, M.D. Michael R. McClung, M.D. Regular Government Employee (RGE) Consultant (voting) Monica Skarulis, M.D. Special Government Employee (SGE) Consultant (non-voting) Robert M. Tuttle, M.D. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ FDA Participants at the Table (non-voting) John Jenkins, M.D., F.C.C.P. Director, Office of New Drugs Robert Meyer, M.D. Director, Office of Drug Evaluation II Jane Axelrad, J.D. Associate Director for Regulatory Policy Mary Parks, M.D. Director, Division of Metabolism and Endocrinology Products Eric Duffy, Ph.D. Director, Division of Post-Marketing Evaluation Cynthia R. D. Selassie, Ph.D. Nozer Singpurwalla, Ph.D. Marc Swadener, Ed.D. Jürgen Venitz, M.D., Ph.D.