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Center | Date | Time | Location |
---|---|---|---|
CDER | December 2, 2005 | 8:00 a.m. - 5:00 p.m. | Hilton |
Agenda:
The committee will discuss new drug application (NDA) 21-514, proposed trade
name METHYPATCH (Methylphenidate) Tdp, (Methylphenidate Transdermal System),
Noven Pharmaceuticals, proposed indication for the treatment of attention deficit
hyperactivity disorder (ADHD).
Background material and meeting information will become available no later than one business day before the meeting (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 November 18, 2005. Oral presentations from the public will
be scheduled 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 November 18, 2005, 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
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FDA welcomes the attendance of the public at its advisory committee meetings
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please contact Cicely Reese at least 7 days in advance of the meeting.
Contact Person:
Cicely Reese, 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: ReeseCi@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 3014512544.