CDERRisk-basedSiteSelectionModelAnFDARisk.pptVIP

FDA Science Board Nov 5, 2004 CDER Risk-based Site Selection Model: An FDA Risk Management Tool Presentation to FDA Science Board November 5, 2004 by Kara Morgan, Ph.D., Office of Planning/Office of the Commissioner Upgrading FDA Risk Management Tools FDA is interested in formalizing risk management tools Rigorous, science-based methods are available Commissioner’s Strategic Plan – Efficient Risk Management Difficult to evaluate efficiency when risk management tools are not formalized OMB Oversight Transparency, Consistency, Accuracy Risk as a meaningful public health metric Motivation for th