Cardiac safety biomarkers

Executive Summary

Biomarkers of cardiac and drug-induced injury will be discussed by the FDA Pharmaceutical Science Advisory Committee/Nonclinical Studies Subcommittee Sept. 9-10. The subcommittee will consider reports from its expert working groups: the cardiotoxicity biomarker working group is preparing a position paper recommending the use of cardiac troponins as a biomarker of cardiac injury (1"The Pink Sheet" Nov. 19, 2001, p. 8). Potential transfer of oversight of the subcommittee to the National Center for Toxicological Research's Science Advisory Board will also be revisited at the meeting. The meeting will be at 5630 Fishers Lane, Rockville, Md., at 1:30 p.m. on Sept. 9 and 8 a.m. on Sept. 10...