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Amended Notice
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 |
Background material and meeting information will become available no later than the day before the meeting (Simply scroll down to the appropriate committee link).
Notice:
The Food and Drug Administration (FDA) is announcing an amendment to the notice
of the meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric
Subcommittee of the Anti-Infective Drugs Advisory Committee. This meeting was
announced in the Federal Register of October 31, 2003 (68 FR 62088). The amendment
is being made to reflect a change in Agenda and Procedure portions
of the document. There are no other changes.
Supplementary Information:
In the Federal Register of October 31, 2003 (68FR
62088), FDA announced that a meeting of the Psychopharmacologic Drugs Advisory
Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory
Committee will be held on February 2, 2004. On page 62088 in the second and
third columns, the Agenda and Procedure portions of the meeting are amended
to read as follows:
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 anti-depressant drugs in pediatric patients with major depressive disorder (MDD). The committee will consider optimal approaches to the analysis of data from these trials as well as further research needs to address these issues. The committee will not be considering options for definitive regulatory action at this meeting because definitive analyses of the data have not been completed. This topic will be covered in a second meeting to be scheduled by summer 2004.
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 9:30 a.m. to 11:30 a.m., and 2 p.m. to 2:30 p.m.