OR WAIT null SECS
CDER 2005 Product Approval Totals Proposed CDER Reorganization
Proposed CDER Reorganization
Washington, DC, Nov. 4 - CDER Director Steve Galson circulated a memo outlining a proposed reorganization that would bring the Center into alignment with FDA's Critical Path Initiative and "improve regulatory and drug development science."
Observing that, "To date, the Center has not been staffed to support needed work on the critical path and has not been configured to provide organizational 'ownership' of these activities." Galson made a series of proposals to support the Critical Path initiative, increase safety oversight, and encourage cross-office activities (see draft organizational chart):
"As I emphasized in my State of CDER address," Galson wrote, "making organizational changes--moving boxes on a chart--only sets the stage upon which the Center priorities can best be addressed. A reorganization is not designed to achieve instant solutions to the challenges CDER faces, although I believe it will address many of the criticisms and suggestions which have been offered on how to approach our work, including drug safety. I truly hope that the proposed realignment will merely create a more efficient and effective environment to further the Center's activities. Other important changes in policy and/or processes (including decision-making) will continue to be discussed and implemented as needed to achieve our shared goals for CDER."