Pharmacoepidemiologic Investigations of Safety Related Issues of Marketed Drugs, and Evaluations of Risks Communications and Management Programs

The FDA requires the ability to quantify product risks and test hypotheses based on signals of possible drug safety problems originating from adverse reaction reports received by the FDA, the medical literature, or from other sources. In addition, the FDA needs to evaluate the overall effectiveness of risk management programs as well as those for specific products and for risk management tools currently in use within these programs. The FDA also needs to evaluate the impact and effectiveness of its risk communications in changing behaviors related to the use of FDA-regulated products. Understanding the nature and root causes of medication errors is another area where collaborative research can benefit the FDA in meeting its public health mission.

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