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Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science

Agenda:
On April 22, 2003, the subcommittee will discuss: 1) quantitative risk-benefit analysis using exposure-response for determining dose adjustment for special populations; and 2) pediatric population pharmacokinetics study design template and analyses of the FDA pediatric database.

On April 23, 2003, the subcommittee will discuss: 1) pharmacogenetics: improvement of existing drug treatments; and 2) drug interactions: metabolism and transport-based.

Procedure:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the subcommittee. Written submissions may be made to the contact person by April 15, 2003. Oral presentations from the public will be scheduled between approximately 12:45 p.m. and 1:15 p.m. on April 22, 2003, and 11:30 a.m. to 12 noon on April 23, 2003. Time allotted for each presentation may be limited. Those desiring to make formal oral presentation should notify the contact person before April 15, 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 Kathleen Reedy at least 7 days in advance of the meeting.

Contact Person:
Kathleen Reedy, 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, or e-mail: reedyk@cder.fda.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12539. Please call the Information Line for up-to-date information on this meeting.

[Full FR Notice]