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| Center | Date | Time | Location |
|---|---|---|---|
| CBER | March 18, 2004 March 19, 2004 |
8:30 a.m. - 5 p.m. 8:30 a.m. - 3 p.m. |
Hilton Hotel |
Agenda:
On March 18 and 19, 2004, the committee will discuss issues related to the design
of early phase clinical trials of cellular therapies for the treatment of cardiac
diseases.
Background material and meeting information will become available no later than the day before the meeting (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 March 11, 2004. Oral presentations from the public will be
scheduled on March 18, 2004, between approximately 4:30 p.m. and 5 p.m.; and
on March 19, 2004, between approximately 9:50 a.m. and 10:20 a.m. Time allotted
for each presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before March 11, 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 Gail Dapolito at least 7 days in advance of the meeting.
Contact Person:
Gail Dapolito or Rosanna Harvey, Center for Biologics Evaluation and Research
(HFM-71), Food and Drug administration, 1401 Rockville Pike, Rockville, MD 20852,
301-827-3014, e-mail: dapolito@cber.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512389. Please call the Information Line
for up-to-date information on this meeting.