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Oncologic Drugs Advisory Committee

Meeting Notice Amended
Click Here to See Amended Notice
To reflect a change in the Date of the meeting.

Agenda:
The committee will discuss the following:

(1) Receive and discuss pediatric update from the October 20, 2005, meeting of the Pediatric Oncology Subcommittee;
(2) discuss pre-clinical requirements and phase 1 trial design issues for the development of oncologic products; and
(3) discuss new drug application (NDA) 20-509, S-039, GEMZAR (gemcitabine hydrochloride) for Injection, Eli Lilly & Co., proposed indication for use in combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based 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 March 7, 2006. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m. and 2:30 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 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.