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Oncologic Drugs Advisory Committee - Pediatric Oncology Subcommittee

Agenda:
The subcommittee will discuss:
(1) Pharmacogenetic testing for thiopurine methyltransferase (TPMT) deficiency in patients for whom treatment with 6-mercaptopurine is being considered; and
(2) overcoming challenges in pediatric oncology product development: regulatory oversight of multi-national clinical studies.

Background material will become available no later than the day before the meeting and will be posted under the Dockets Management Branch site at http://www.fda.gov/ohrms/dockets/ac/03acdocs.htm. (Scroll down and select the appropriate advisory committee link.)

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 July 7, 2003. Oral presentations from the public will be scheduled between approximately 10:00 a.m. and 10:30 a.m. and 1:00 p.m. and 1:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before July 7, 2003, 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 Thomas Perez at least 7 days in advance of the meeting.

Contact Person:
Thomas H. Perez, 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, by phone at 301-827-6758, by e-mail at PerezT@cder.fda.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12542. Please call the Information Line for up-to-date information on this meeting.

[Full FR Notice]

FDA Website Management Staff