Panel to evaluate FDA pharmacogenomics paper

Executive Summary

FDA will convene its Pharmaceutical Science and Clinical Pharmacology Advisory Committee March 18 to evaluate the agency's clinical pharmacogenomics concept paper. Industry is requesting that FDA clarify elements of the companion guidance, and the panel will discuss issues pertaining to collection of samples and applications of pharmacogenomics in clinical development (1"The Pink Sheet," Dec. 10, 2007, p. 18). The panel also will address qualitative clinical pharmacology. On March 19, the panel will discuss the renal impairment concept paper...