CDER Reorganization Takes Effect, With Renamed Offices
This article was originally published in The Pink Sheet Daily
Executive Summary
Safety functions and Critical Path activities are the focus of new CDER offices.
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FDA's Office of Surveillance & Epidemiology (OSE) -formerly the Office of Drug Safety - reports directly to the Center for Drug Evaluation & Research director effective May 15, fulfilling the center's reorganization announced last November. Gerald Dal Pan, who took the position of ODS director in November, still heads the renamed office. The new name more accurately reflects the office's functions, FDA said. The elevation of the safety office is accompanied by a new position in the Office of the Center Director, also announced in the fall (1 (Also see "CDER Reorganization Will Create Center-Level Associate Director For Safety" - Pink Sheet, 4 Nov, 2005.)). Former Office of Pharmacoepidemiology & Statistical Science (OPaSS) Director Paul Seligman has assumed the role of Associate Director for Safety Policy & Communication, CDER director Steven Galson said May 15. Seligman will focus on "broad drug safety policy and safety communication" and will oversee MedWatch and the Drug Safety Oversight Board staff. The reorganized safety functions are intended to "sustain a multi-disciplinary, cross-center approach to drug safety," Galson said. The new office formed to oversee Critical Path activities has been dubbed the Office of Translational Sciences (OTS). Previously described by the agency as a "super-office," OTS includes the Office of Clinical Pharmacology, the Office of Biostatistics and support for "cross-cutting science programs" such as Critical Path. Shirley Murphy is the OTS director. Murphy previously served as Acting Deputy Director of the Office of Counter-Terrorism & Pediatric Drug Development. Pediatric drug development has been moved to the Office of New Drugs, leaving the renamed Office of Counter-Terrorism & Emergency Coordination, under the direction of Rosemary Roberts. OPaSS has been eliminated, with its functions split between OSE and OTS. -Christopher Walker |