FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Meeting
Notice Amended
Click Here to See Amended
Notice
To reflect a changes in the Date,
Time, and Procedure portions of the meeting.
Center | Date | Time | Location |
---|---|---|---|
CDER | March 7, 2006 | 8:00 a.m. - 5:00 p.m. | Holiday Inn Gaithersburg |
Agenda:
The committee will discuss TYSABRI (natalizumab) biologic license application
125104/15; Biogen Idec Inc., for an indication in patients with relapsing forms
of multiple sclerosis to reduce the frequency of clinical exacerbations. The
committee will discuss the risks (including progressive multifocal leukoencephalopathy)
associated with TYSABRI (natalizumab) administration, its efficacy in the treatment
of multiple sclerosis relapses and/or disability, its possible return to the
marketplace, and its proposed risk management plan(s).
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 February 28, 2006. 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 February 28, 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 Sohail Mosaddegh at least 7 days in advance of the meeting.
Contact Person:
Sohail Mosaddegh, 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: mosaddeghs@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 3014512543.