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Center | Date | Time | Location |
---|---|---|---|
CDER | June 02, 2004 June 03, 2004 |
8 a.m. - 5 p.m. | Food and Drug
Administration |
Agenda:
On June 2, 2004, the committee will discuss trial design and endpoints for drugs
for chronic gout, including new drug application (NDA) 21-740, oxypurinol (proposed
tradename, OXIPRIM), Cardiome.
On June 3, 2004, the committee will discuss trial design and endpoints for drugs
for acute gout, including NDA 21-389, etoricoxib (proposed tradename, ARCOXIA),
Merck.
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 May 19, 2004. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should notify
the contact person before May 19, 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 Kimberly Littleton Topper at 301-827-7001, at least 7 days in
advance of the meeting.
Contact Person:
Kimberly Littleton Topper, Center for Drug Evaluation and Research (HFD-21),
Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630
Fishers Lane, Rm. 1091), Rockville, MD 20857, 301-827-7001, Fax: 301-827-6801,
or e-mail: topperk@cder.fda.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 3014512532. Please call the Information Line for
up-to-date information on this meeting.
[ Full FR Notice ]