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Center | Date | Time | Location |
---|---|---|---|
CDER | June
2, 2006 |
10:00 a.m. - 2:00 p.m. | Omni Hotel at
CNN Center |
Agenda:
The committee will discuss new drug application (NDA) 21-986, proposed trade
name SPRYCEL (dasatinib) tablets, Bristol-Myers Squibb Co., with proposed indications
for the: (1) Treatment of adults with chronic, accelerated, or blast phase chronic
myeloid leukemia with resistance or intolerance to prior therapy including imatinib
and (2) treatment of adults with Philadelphia chromosome-positive acute lymphoblastic
leukemia, and lymphoid blast chronic myeloid leukemia with resistance or intolerance
to prior therapy.
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 May 18, 2006. Oral presentations from the public will be scheduled
between approximately 12 noon and 1:00 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should notify
the contact person before May 18, 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 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: Johanna.Clifford@fda.hhs.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.