|
|
|
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Meeting Notice
Amended
Click Here to See Amended
Notice
To reflect cancellation of the closed portion of the meeting and changes in
the Date and Time, Agenda, Procedure, and Closed Committee
Deliberations portions of the meeting.
Original Notice Below
| Center | Date | Time | Location |
|---|---|---|---|
| CBER | March 3, 2005 March 4, 2005 |
8 a.m. - 5:15 p.m. 8 a.m. - 2:30 p.m. |
Quality Suites |
Agenda:
On March 3-4, 2005 the Committee will discuss cellular therapies for repair
and regeneration of joint surfaces.
- An announcement of other agenda items to be added to this meeting is forthcoming.
| The following topics originaly scheduled have been cancelled: The Committee will also receive the following updates: 1) on March 3, 2005, in the afternoon, updates of research programs in the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research; 2) on March 4, 2005, in the morning, update on the FDA Critical Path Initiative. |
Background material and meeting information will become available no later than one business day before each meeting day (Simply select the appropriate committee link).
Closed Committee Deliberations:
On March 3, 2005 from approximately 4:45 p.m. to 5:15 p.m., 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
research programs in the Center for Biologics Evaluation and Research and the
Center for Drug Evaluation and Research.
Procedure:
On March 3, 2005, from 8 a.m. to approximately 4:45 p.m. and on March 4, 2005
from 8 a.m. to approximately 2:30 p.m., the meeting is open to the public. 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 February 23, 2005. Oral presentations from the public will be scheduled
on March 3, 2005 between approximately 11 a.m. and 11:30 a.m. and on March 4,
2005 between approximately 8:45 a.m. and 9:15 a.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should notify
the contact person before February 23, 2005 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 L. Harvey, Center for Biologics Evaluation and Research
(HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852,
(301) 827-0314, 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.