FDA reorganizes CDER

FDA reorganized its Center for Drug Evaluation and Research, according to an internal agency memo. Robert Temple has been named deputy director for clinical science and will focus on clinical science guidances and policies. Temple will continue as acting director of the Office of Drug Evaluation 1, which is responsible for cardio-renal, neuropharmacologic and psychopharmacologic drug products.

Rachel Behrman, who has served as director of the Office of Critical Path Programs since 2005, is replacing Temple as acting director, Office of Medical Policy. The office has responsibility for regulating drug promotion. In addition, she has been named acting associate center director for medical policy. FDA has not named a new Critical Path leader. ...