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Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science

Agenda:
On November 14, 2005, the subcommittee will: (1) Receive an update on previous Clinical Pharmacology Subcommittee meeting recommendations and an introduction to the topics of this meeting, (2) discuss and provide comments on the evidence and process for translation of pharmacogenetic information (e.g., Cytochrome P 2C9 polymorphisms) into label updates for approved products, (3) discuss current evidence related to the pharmacogenetics of warfarin as a potential basis for label updates, and (4) discuss and provide comments on the critical path pilot project, the End-of-Phase 2A meetings which will include a case study.

On November 15, 2005, the subcommittee will discuss and and provide comments on: (1) An update on the critical path biomarker-surrogate endpoint project, (2) the use of biomarker information in labels to facilitate individualizing pharmacotherapy, and (3) the analytical and clinical validation criteria for approving a clinical assay ("diagnostic test").

Background material and meeting information will become available no later than one business day before each meeting day (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 November 4, 2005. Oral presentations from the public will be scheduled between approximately 11:15 a.m. and 11:30 a.m. and 3:35 p.m. and 3:50 p.m. on November 14, 2005, and between approximately 11:20 a.m. and 11:50 a.m. on November 15, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before November 4, 2005, 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 Mimi Phan at least 7 days in advance of the meeting.

Contact Person:
Mimi Phan, 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: phanm@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 3014512539.