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Center | Date | Time | Location |
---|---|---|---|
CDER | March 23, 2006 | 8:00 a.m. - 5:00 p.m. | Hilton Washington
DC North |
Agenda:
The committee will discuss new drug application (NDA) 20-717, S-019, PROVIGIL
(100 milligrams (mg), 200 mg, 85 mg, 170 mg, 255 mg, 340 mg, and 425 mg) Tablets,
Cephalon, Inc.; the proposed indication is 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 March 15, 2006. Oral presentations from the public will be
scheduled between approximately 1:00 p.m. and 2:00 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before March 15, 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 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.