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FDA Office Of Drug Safety Director Is Surveillance Division Head Dal Pan

This article was originally published in The Tan Sheet

Executive Summary

FDA is turning to five-year agency veteran Gerald Dal Pan to permanently fill the high-profile role of Office of Drug Safety director

FDA is turning to five-year agency veteran Gerald Dal Pan to permanently fill the high-profile role of Office of Drug Safety director.

Dal Pan has served as the director of the Office of Drug Safety's Division of Surveillance, Research & Communication Support since the end of 2003. He will officially begin as ODS director Nov. 13.

FDA's Oct. 19 announcement of a permanent ODS director comes two years after the departure of former ODS Director Victor Raczkowski in October 2003.

Since that time, the position has been filled on an acting basis, first by Office of Pharmacoepidemiology & Statistical Sciences Director Paul Seligman and then by FDA Emergency Preparedness Officer Ralph Lillie.

FDA renewed and expanded its search for an ODS director in November 2004 and posted a position description on the federal government's job site in June (1 'The Tan Sheet' July 4, 2005, In Brief).

Dal Pan joined FDA in 2000 from Guilford Pharmaceuticals, where he directed clinical research. Prior to becoming director of DSRCS in 2003, Dal Pan was a medical reviewer in the Division of Anesthetic Critical Care & Addiction Drug Products. He also is a part-time assistant professor in the neurology department of Johns Hopkins University School of Medicine.

FDA said the ODS director's responsibilities will include working with patient groups, the healthcare community and Congress; maintaining contacts with regulators; and implementing drug safety initiatives, such as FDA's Drug Safety Oversight Board.

Anne Trontell will continue to serve as ODS deputy director; a successor to Dal Pan as head of DSRCS has not yet been appointed.

In conjunction with the announcement of Dal Pan's new position, plans for a reorganization of the Center for Drug Evaluation & Research were outlined by CDER Director Steven Galson.

One goal of the proposed reorganization is increased visibility of FDA's drug safety efforts. An announcement of specific changes is expected by November.

[ Editors' note: This story was contributed by 2 "The Pink Sheet" DAILY , your daily source for prescription drug news. For more information call 1-800-332-2181.]

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