Food and Drug Administration

Center for Drug Evaluation and Research

Nonclinical Studies Subcommittee of the

Advisory Committee for Pharmaceutical Science

September 9-10, 2002

Committee Conference Room, 5630 Fishers Lane

Rockville, MD


Monday September 9

1:00 Welcome and Introductions J. Doull

Meeting Statement K. Reedy

1:10 Introductory Comments J. Doull

J. MacGregor

1:30 Report of the Cardiotoxicity Expert K. Wallace
Working Group

2:30 Subcommittee Discussion of Cardiotoxicity J. Doull
Expert Working Group Report

3:00 Break

3:15 Administrative Oversight of the Subcommittee J. MacGregor

4:00 Subcommittee Discussion J. Doull

4:30 Adjourn

Tuesday, September 10

8:00 Report of the Vascular Injury W. Kerns
Expert Working Group L. Schwartz

9:00 Subcommittee Discussion of Vascular J. Doull
Injury Expert Working Group Report

10:00 Break

10:15 Open Public Hearing

11:00 Subcommittee Discussion J. Doull

12:00 Adjourn