Transcript for the March 24, 2010 Veterinary Medicine Advisory Committee
U.S. Food and Drug Administration
Veterinary Medicine Advisory Committee (VMAC)
Modification of ProHeart® 6 RiskMAP (NADA 141-189)
March 24, 2010
Michael Doyle, Ph.D., Acting Chair
Craig Altier, D.V.M., Ph.D.
Michael Apley, D.V.M., Ph.D.
Dicky D. Griffin, D.V.M.
Alan G. Mathew, Ph.D.
James D. McKean, D.V.M., J.D.
Michael Murtaugh, Ph.D.
Robert Poppenga, D.V.M., Ph.D.
David F. Senior, A.C.V.I.M.N.-S.A., E.C.V.I.M.
Michael Wolf, Ph.D., M.A., M.P.H.
Adjournment was at 3:35 p.m.
Keynote: “---” indicates inaudible in the transcript.
“*” indicates phonetically spelled in the transcript.
Index - Morning Session (8:34 a.m.)
Welcome and Opening Remarks by Dr. Bernadette Dunham, Director, CVM Background by Dr. Daniel McChesney, Director, Office of Surveillance and Compliance, CVM Regulatory Framework by Janice Steinschneider, Regulatory Counsel, Office of Surveillance and Compliance, CVM Pfizer Animal Health by Stephen Sutherland, D.V.M. and Tatty Hodge, D.V.M., M.S. Risk Maps and Labeling by Dr. Martine Hartogensis, Deputy Director, Office of Surveillance and Compliance, CVM Data Analysis by Dr. John Baker, Veterinary Medical Officer, Division of Surveillance, CVM Questions and Answers - Moderator, Dr. Bernadette Dunham
Index - Afternoon Session (1:00 p.m.)
Open Public Hearing - Moderator, Aleta Sindelar, CVM Executive Secretary Clarification of VMAC Questions - Moderator, Dr. Michael Doyle, Acting Chair Committee Deliberations - Question #1, Part 1 (Moderator, Dr. Michael Doyle) Committee Deliberations - Question #1, Part 2 (Moderator, Dr. Michael Doyle) Committee Deliberations - Question #2 (Moderator, Dr. Michael Doyle)