FDA Drug Safety and Risk Management Advisory Committee

Anybody got an opinion about the upcoming ADHD drug
hearings. Time to get
them in!!
http://ablechild.org/a
lert.htm
FDA Drug Safety and Risk Management Advisory Committee
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
Two Montgomery Village Ave.
Gaithersburg, MD


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: ferrettiVcder.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.


[Non-text portions of this message have been removed]



 
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