Food and Drug Administration
Center for Biologics Evaluation and Research
Cellular, Tissue and Gene Therapies Advisory Committee
Meeting # 43
March 30, 2007
Hilton Hotel,
DRAFT AGENDA
Open Committee Discussion – Guidance
for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical
Cord Blood Intended for Hematopoietic Reconstitution in Patients with
Hematological Malignancies
8:00 a.m. Welcoming Remarks
James Mulé, Ph.D., Chair
Conflict of Interest Statement
Gail Dapolito, Executive Secretary
Introduction of Members
James Mulé, Ph.D.
8:10 FDA Introduction
8:30 Pablo Rubinstein, M.D., Director
National Cord Blood Program
9:10 Q&A
9:20 FDA Presentation
10:00 Q&A
10:10 Break
10:30 Open Public Hearing
11:30 Lunch
12:30 p.m. Questions for Committee Discussion
3:00 p.m. Adjourn