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| Center | Date | Time | Location |
|---|---|---|---|
| CDER | May 16, 2003 | Cancelled | Holiday Inn |
Agenda:
The committee will discuss supplemental new drug application (sNDA) 20-690,
supplement SE1-020, ARICEPTR (donepezil hydrochloride tablets), Eisai Medical
Research Inc., indicated for the treatment of vascular dementia. The background
material will become available no later than the day before the meeting and
will be posted under the Peripheral and Central Nervous System Drugs Advisory
Committee docket site at /ohrms/dockets/ac/acmenu.htm.
(Click on the year 2003 and scroll down to the Peripheral and Central Nervous
System Drugs Advisory Committee meetings.)
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 May 9, 2003. Oral presentations from the public will be scheduled
between approximately 1:30 p.m. and 2:30 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should notify
the contact person before May 9, 2003, 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 Karen Templeton-Somers at least 7 days in advance of the meeting.
Contact Person:
Karen M. Templeton-Somers, Center for Drug Evaluation and Research (HFD-21),
Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630
Fishers Lane, rm. 1093) Rockville, MD 20857, 301-827-7001, or e-mail: somersk@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12543. Please call the Information Line for up-to-date
information on this meeting.
[Full FR Notice] [FR Cancellation Notice]
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