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Meeting Notice
Amended
Changes in the Agenda and Procedure portions
of the meeting.
| Center | Date | Time | Location |
|---|---|---|---|
| CDER | February 2, 2004 | 8 a.m. - 5 p.m. | Holiday Inn |
Agenda:
The Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee
of the Anti-Infective Drugs Advisory Committee will discuss reports of the occurrence
of suicidality (both suicidal ideation and suicide attempts) in clinical trials
for various antidepressant drugs in pediatric patients with major depressive
disorder (MDD). The committee will consider optimal approaches to the analysis
of data from these trials, and the results of analyses conducted to date, with
regard to the question of what regulatory action may be needed pertinent to
the clinical use of these products in pediatric patients. The committee will
also consider further research needs to address questions on this topic.
Background material and meeting information will become available no later than the day before the meeting (Simply scroll down to 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 January 26, 2004. Oral presentations from the public will
be scheduled between approximately 8:15 a.m. to 9:15 a.m., and 1 p.m. to 1:30
p.m. Time allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before January 26,
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 Anuja Patel at least 7 days in advance of the meeting.
Contact Person:
Anuja Patel, 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 e-mail: patelA@cder.fda.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 3014512544. Please call the Information Line for
up-to-date information on this meeting.