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Center | Date | Time | Location |
---|---|---|---|
CDER | March 14, 2006 | 8:00 a.m. - 5:00 p.m. | Gaithersburg Hilton |
Agenda:
The subcommittee will discuss the following:
(1) Clinical studies of methotrexate and daunomycin to be conducted under the
Best Pharmaceuticals for Children Act;
(2) phase 4 requirements for Deferasirox, Norvartis Pharmaceuticals, as mandated
under accelerated approval; and
(3) the Center for Drug Evaluation and Research's process for handling drug
shortages.
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 7, 2006. Oral presentations from the public will be
scheduled between approximately 2 p.m. to 3 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should notify
the contact person before March 7, 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 Johanna M. Clifford at least 7 days in advance of the meeting.
Contact Person:
Johanna M. Clifford, 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:
cliffordj@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 3014512542.