|
|
|
FDA Home Page | Search FDA Site | A-Z Index | Contact FDA
| Center | Date | Time | Location |
|---|---|---|---|
| CDER | June 23, 2003 June 24, 2003 |
8:00 a.m. - 5:00
p.m. 8:00 a.m. - 5:00 p.m. |
Holiday Inn |
Agenda:
On June 23, 2003, the committee will discuss fibromyalgia, clinical trial design,
including important disease endpoints, in the study and development of therapies
and treatments.
On June 24, 2003, the committee will discuss the safety and efficacy of submission tracking number (STN) 103795/5123, ENBREL (etanercept), Immunex, for reducing signs and symptoms of active ankylosing spondylitis.
Background material will become available no later than the day before the meeting and will be posted under the Dockets Management Branch site at http://www.fda.gov/ohrms/dockets/ac/03acdocs.htm. (Scroll down and select the appropriate advisory 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 June 13, 2003. Oral presentations from the public will be
scheduled between approximately 11:30 a.m. to 12:00 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before June 13, 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 LaNise Giles at 301-827-7001 at least 7 days in advance of the
meeting.
Contact Person:
Johanna Clifford, 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, Fax: 301-827-6776
or email: cliffordj@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12532. Please call the Information Line for up-to-date
information on this meeting.