Exploratory IND Concept Needs Expansion, Merck Exec Says
Executive Summary
FDA should expand its "Exploratory IND" guidance to make it easier for manufacturers to do pilot studies involving radioactive tracers, Merck Division of Imaging Senior Director David Mozley told a May 5 meeting on "Critical Path" opportunities cosponsored by FDA, the Biotechnology Industry Organization and the Drug Information Association in Bethesda, Md