FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Meeting
Notice Amended
Click Here to See Amended Notice
To reflect a change in the Time
and Agenda of the meeting.
Agency | Date | Time | Location |
---|---|---|---|
FDA | March 22, 2006 | 8:00 a.m. - 6:00 p.m. | Washington DC
North |
Agenda:
The Pediatric Advisory Committee will hear and discuss a report by the agency,
as mandated in Section 17 of the Best Pharmaceuticals for Children Act (BPCA),
on adverse event reports possibly related to clofarabine (CLOLAR), irbesartan
(AVAPRO), sibutramine (MERIDIA), and the mixed salts amphetamine product (ADDERALL).
In continuation of a prior committee discussion of adverse events for the class
of methylphenidate products used to treat attention deficit hyperactivity disorder
(ADHD), the committee will hear and discuss neuropsychiatric adverse events
possibly related to other approved ADHD medications. The presentations will
focus on neuropsychiatric adverse event reports and clinical trial data from
approved ADHD medications. The committee will also receive an update on efforts
to better understand cardiovascular adverse events possibly related to ADHD
medications.
Background material and meeting information will become available no later than one business 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 March 8, 2006. Oral presentations from the public will be
scheduled on March 22, 2006 between approximately 1 p.m. and 2 p.m. Time allotted
for each presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before March 8, 2006, 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 Jan N. Johannessen at least 7 days in advance of the meeting.
Contact Person:
Jan N. Johannessen, Office of Science and Health Coordination,
Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers
Lane, (for express delivery, Rm. 14C-06) Rockville, MD 20857, 301-827-6687,
e-mail: Jan.Johannessen@fda.hhs.gov
Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this
meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 8732310001.