FDA Risk Management Workshop – Day #2 April 10, 2003
Relevant History
Major Barriers to Drug Safety Profile Characterization
FDA’s Post-Marketing Risk Management Strategy (RMS)
FDA’s Post-Marketing Risk Management Strategy Requires…
The quality and type of current Postmarket safety data is the “Achilles Heel” of FDA’s Risk Management Strategy
PPT Slide
PMS Data for Labeling Updates
Relative Safety Claims in Labeling: What Standard of Evidence ?
“substantial clinical experience”
Ironically: FDA’s current interpretation of the regulations have been one of the barriers that has prevented the acquisition of the quality data needed for risk management and for rational drug therapy !
FACTS!
The dilemma!
Merge Goals
FDA Question #1 Consideration on what comprises and prompts a risk management program
FDA Question #2 The selection and development of risk management tools
FDA Question #3 The evaluation of risk management programs
FDA Question #4 The recommended elements of a risk management program submission to FDA
Home Page: http://www.fda.gov/cder/meeting/riskManagement.htm
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