FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Center | Date | Time | Location |
---|---|---|---|
CBER | July 22, 2004 July 23, 2004 |
8 a.m. - 6 p.m. 8 a.m. - 3 p.m. |
Holiday Inn Gaithersburg |
Agenda:
On July 22, 2004, the committee will hear updates on: FDA current thinking on
transfusion related acute lung inflammation (TRALI), and donor blood pressure
determination. The committee will also discuss and provide recommendations on
the dating of irradiated blood. In the afternoon, the committee will discuss
and provide recommendations on the new standards for platelet evaluation and
experience with monitoring of bacterial contamination of platelets.
On July 23, 2004, the committee will hear an update on West Nile Virus. The committee will also hear presentations, discuss and provide recommendations on hepatitis B virus nucleic acid testing (HBV NAT) for mini-pools. In the afternoon, there will be an informational presentation on current trends in plasma product manufacturing.
Background material and meeting information will become available no later than one business day before each meeting day (Simply select the appropriate committee link).
Procedure:
Interested persons may present data, information, or views, orally or in writing,
on issues pending before the committee. Written submissions may be made to the
contact person by July 12, 2004. Oral presentations from the public will be
scheduled between approximately 8:35 a.m. and 9 a.m., 11 a.m. and 11:30 a.m.,
2 p.m. and 2:30 p.m., and 4:30 p.m. and 5 p.m. on July 22, 2004; and between
approximately 10:15 a.m. and 11:15 a.m. and 2 p.m. and 2:30 p.m. on July 23,
2004. Time allotted for each presentation may be limited. Those desiring to
make formal oral presentations should notify the contact person before July
12, 2004, and submit a brief statement of the general nature of the evidence
or arguments they wish to present, the names and addresses of proposed participants,
and an indication of the approximate time requested to make their presentation.
Persons attending FDA's advisory committee meetings are advised that the agency
is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings
and will make every effort to accommodate persons with physical disabilities
or special needs. If you require special accommodations due to a disability,
please contact Linda A. Smallwood, or Pearline K. Muckelvene at 301-827-1281
at least 7 days in advance of the meeting.
Contact Person:
Linda A. Smallwood, Center for Biologics Evaluation and Research (HFM-302),
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-3514,
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.