|
|
|
FDA Home Page | Search FDA Site | A-Z Index | Contact FDA
| Center | Date | Time | Location |
|---|---|---|---|
| CDER | June 16, 2003 | 8:00 a.m. - 5:00 p.m. | Marriott
Washingtonian Center |
Agenda:
On June 16, 2003, the committee will discuss the white blood cell (WBC) monitoring
schedule for patients being treated long-term with clozapine. Currently, the
WBC monitoring schedule is weekly for the first six months of continuous therapy,
and biweekly thereafter. The committee will consider the question of whether
the frequency of WBC monitoring can be diminished further following some period
of biweekly monitoring.
When available, background materials for this meeting will be posted one business
day prior to the meeting on the FDA web site at: http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
(Click on the year 2003 and scroll down to Psychopharmacologic Drugs Advisory
Committee.)
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 9, 2003. Oral presentations from the public will be scheduled
between approximately 1:00 p.m. - 2:00 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should notify
the contact person before June 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 Jayne Peterson at least 7 days in advance of the meeting.
Contact Person:
Jayne E. Peterson, 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, petersonj@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12544. Please call the Information Line for up-to-date
information on this meeting.