Comments on FDA Concept Paper
General comments on risk management
Premarketing Risk Assessment - omission
Trial size – acute use / serious conditions
Trial size – chronic use
Subgroup analysis
Detection of unanticipated interactions
Biomarkers - caveats
Biomarkers - suggestions
Optimizing AE descriptions for signal detection - I
Optimizing AE descriptions for signal detection - II
Additional viewpoint – CIOMS-VI (working draft)
Thank you
Home Page: http://www.fda.gov/cder/meeting/riskManagement.htm
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