Blood Products Advisory Committee
September 29, 2005 MeetingDate and Time:
The meeting will be held on September 29, 2005; 8:00 am to 5:00 pm
Location:
Food and Drug Administration, CDER Advisory Committee Conference Room, Room 1066, 5630 Fishers Lane, Rockville, MD 20852.
Contact Persons:
Donald W. Jehn or Pearline Muckelvene, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting.
Agenda:
The Committee will discuss new drug application (NDA) 21-882 proposed trade name Exjade (deferasirox) Tablets for Oral Suspension, Novartis Pharmaceutical Corporation, proposed for the indication of the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis). Following this discussion, the committee will hear an overview of the research programs in the Laboratory of Hemostasis and the Laboratory of Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, CBER, and in closed session will discuss the report from the laboratory site visit of February 25, 2005.
Oral Presentations:
Between approximately 11:15 a.m. and 12:15 p.m. oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before September 22, 2005.
Closed Committee Deliberations:
From approximately 4:15 pm to 5:00 pm the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c) (6)). The Committee will discuss a review of internal research programs in the Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research.