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Center | Date | Time | Location |
---|---|---|---|
CDER | February 9, 2006 February 10, 2006 |
8:00 a.m. - 5:00
p.m. 8:00 a.m. - 3:00 p.m. |
Holiday Inn Gaithersburg |
Agenda:
Cases of sudden death and serious adverse events including hypertension, myocardial
infarction, and stroke have been reported to the agency in association with
therapeutic doses of drugs used to treat Attention Deficit Hyperactivity Disorder
(ADHD) in both pediatric and adult populations. The few controlled clinical
studies of longer term drug treatment of ADHD provided little information on
cardiovascular risks.
On February 9, 2006, the committee will be asked to discuss approaches that could be used to study whether these products increase the risk of adverse cardiovascular outcomes.
On February 10, 2006, the committee will be briefed on developments in the Office of Drug Safety and will receive updates on the Drug Safety Oversight Board and agency actions for the COX-2 selective Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and the risk management program for the isotretinoin products.
Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).
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 February 2, 2006. Oral presentations from the public will
be scheduled between approximately 1 p.m. and 2 p.m. on February 9, 2006, and
between approximately 8:15 a.m. and 9:15 a.m. on February 10, 2006. Time allotted
for each presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before February 2, 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 Victoria Ferretti-Aceto at least 7 days in advance of the meeting.
Contact Person:
Victoria Ferretti-Aceto, Center for Drug Evaluation and Research (HFD-21), Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001,
FAX: 301-827-6776, e-mail: ferrettiV@cder.fda.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 3014512535.