FOOD AND DRUG ADMINISTRATION
Center for Drug
Evaluation and Research
ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING
DRAFT AGENDA
December
16, 2003
Advisors and Consultants Conference Room, Rockville, Maryland
8:00 a.m. Call
to Order Donna
Przepiorka, M.D., Chair, ODAC
Introduction of
Committee
Conflict of Interest
Statement Johanna Clifford, M.S., RN, BSN
Executive
Secretary, ODAC
8:10 a.m. Opening Remarks
8:15 a.m. General Regulatory
Background
8:25 a.m. Endpoints for Past Approvals
8:35 a.m. Time to Progression Endpoint
8:55 a.m. Challenges in Oncology
Clinical Trials
9:25 a.m. Clarification Questions to
Presenters
9:35 a.m. Break
9:50 a.m. Open Public Hearing
10:20 a.m. Questions for Discussion
12:00 p.m. Lunch
1:00 p.m. NSCLC Regulatory Background
1:20 p.m. FDA/ASCO
NSCLC Workshop Summary .
1:50 p.m. Patient Reported Outcomes in
NSCLC
2:05 p.m. Clarification Questions to
Presenters
2:15 p.m. Break
2:30 p.m. Open Public Hearing
3:00 p.m. Questions for Discussion
5:00 p.m. Adjourn