Last week's announcement that Bob Temple is giving up his role as acting director of FDA's Office of Drug Evaluation 1 - while continuing to serve as deputy center director for clinical science - marks a sea change for drug regulation.

For most of the last 35 years, Temple has been in charge of FDA's cardiology and renal drug reviews, and for the last 17 years he also has had the final say on neuropharmacologic and psychopharmacologic drug products.