The post-market surveillance studies can be a crucial element in a comprehensive risk management plan for a proposed OTC drug. While it is necessary to demonstrate safety before approval, not all relevant safety questions can be answered with prospective, pre-approval research. In some instances, it may be necessary to make post-approval commitments for research to assess certain aspects of use or outcome. Although there is an established sets of procedures for post-market surveillance of prescription drugs, the OTC environment requires novel approaches. We have done some of these studies and have developed methods for gathering data from actual OTC users.
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