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| Center | Date | Time | Location |
|---|---|---|---|
| CBER | April 7, 2005 | 8:30 a.m. - 4 p.m. | Holiday Inn Select |
Agenda:
The Committee will discuss a proposed strategy for the reclassification of Class
IIIA allergenic products. The Committee will also receive an update of the FDA
Critical Path Initiative.
Background material and meeting information will become available no later than one business 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 31, 2005. Oral presentations from the public will be
scheduled between approximately 11:15 a.m. and 12:15 p.m.. Time allotted for
each presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before March 31, 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 Jane Brown, 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 3014512388. Please call the
Information Line for up-to-date information on this meeting.
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