Table of Contents
Concept Paper: Risk Management Programs
Utility of Risk Management Programs
Overburdening Healthcare System
Pre-testing new methods
Limitations of Spontaneous Reports
Acceptable Levels of Impact
Iterative Aspects of Risk Management Programs
Flexibility in the Elements of the Program
Additional Questions for the FDA
How will Evaluation of the RMP be Carried Out?
How will FDA Ensure that RMPs are Consistently Applied?
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Home Page: http://www.fda.gov/cder/meeting/riskManagement.htm
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