Pharmacogenetics in labeling

Executive Summary

FDA's Clinical Pharmacology Subcommittee topics will include translation of pharmacogenetic information into label updates during a Nov. 14-15 meeting. Discussion of FDA's "Critical Path" initiative will occur on both days of the meeting. On Nov. 14, the subcommittee will discuss "end-of-Phase IIa" meetings. On 1Nov. 15, meeting topics will include several Critical Path-related issues, including the use of biomarker information in labels to facilitate individualizing pharmacotherapy. The meeting will be held at CDER's advisory committee conference room at 5630 Fishers Lane in Rockville, Md., beginning at 8:30 a.m. both days...