Food and Drug Administration
Center for Drug Evaluation and Research
Oncologic Drugs Advisory Committee
Holiday Inn - Bethesda, Maryland
Tentative AgendaJune 7, 2001
8:00 Call to Order and Opening Remarks Stacy Nerenstone, M.D.
Introduction of Committee
Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Executive Secretary, ODAC
Open Public Hearing
Single Patient Use of Non-approved Oncology Drugs and Biologics
Summary of Regulatory and Industry Considerations Grant Williams, M.D.
Medical Team Leader, DODP, CDER
9:20 Summary of the Ethical Considerations Sarah Taylor, M.D.
9:40 Perspective from the Patient Advocacy Community Jody Pelusi, F.N.P., Ph.D.
10:15 Committee Discussion
ODAC Discussants Sarah Taylor, M.D.
Jody Pelusi, F.N.P., Ph.D.