Food and Drug Administration

Food and Drug Administration

Center for Drug Evaluation and Research

Oncologic Drugs Advisory Committee

67^th Meeting

Holiday Inn - Bethesda, Maryland

Tentative Agenda June 7, 2001

8:00 Call to Order and Opening Remarks Stacy Nerenstone, M.D.

Chair, ODAC

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

9:00 Introduction

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.

ODAC Member

9:40 Perspective from the Patient Advocacy Community Jody Pelusi, F.N.P., Ph.D.

ODAC Member

10:00 Break

10:15 Committee Discussion

ODAC Discussants Sarah Taylor, M.D.

ODAC Member

Jody Pelusi, F.N.P., Ph.D.

ODAC Member

12:00 Adjourn