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Meeting Notice
Amended
Changes in the Procedure portion of the
meeting.
Center | Date | Time | Location |
---|---|---|---|
CDER and Office of the Commissioner |
September 13, 2004 September 14, 2004 |
8 a.m. - 6:30 p.m. 8 a.m. - 5 p.m. |
Holiday Inn |
Agenda:
The Psychopharmacologic Drugs Advisory Committee and the Pediatric 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 and other psychiatric
disorders. Preliminary risk data based on the classification of these adverse
event reports by the pharmaceutical sponsors of these products were presented
at the joint meeting of the Psychopharmacologic Drugs Advisory Committee and
the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee held
on February 2, 2004. Since that meeting, experts in pediatric suicidality, assembled
by Columbia University, have independently classified these reported events,
and FDA has conducted an analysis of these data.
On September 13 and 14, 2004, the committees will consider the results of FDA’s analysis of these independently classified events and will consider what further regulatory action may be needed with regard to the clinical use of these products in pediatric patients. The committees will also consider further research needs to address questions on this topic.
Background material and meeting information will become available no later than one business day before each meeting day (Simply select the appropriate committee link).
Addresses:
Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments.
Select ‘‘2004N–0330—Suicidality in Clinical Trials for
Antidepressant Drugs in Pediatric Patients’’ and follow the prompts
to submit your statement. Written comments should be submitted to the Division
of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. Comments received by August 23, 2004, will
be provided to the committee before the meeting. Comments received after August
23, 2004, will be reviewed by FDA’s decision makers.
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 August 23, 2004, as previously stated (see Addresses).
Oral presentations from the public will be scheduled between approximately 2
p.m. to 6 p.m. on September 13, 2004. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should notify the
contact person before August 27, 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 301–827–7001, 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, 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.
[ Full FR Notice ]