The Food and Drug Administration Amendments Act (FDAAA) of 2007 mandated that FDA “create a robust system to identify adverse events and potential drug safety signals.” Federal Food, Drug, and Cosmetic Act Section 505(k)(3)(C)(i)(3)(cc) (21 U.S.C. 355(k)(3)(C)(i)(III)(cc)). FDA defines signal identification as a process of systematically evaluating potential adverse events related to the use of medical products without prespecifying an outcome of interest. Several statistical approaches exist in Sentinel that can be applied to the electronic healthcare data to detect new and unsuspected potential safety concerns. These analytic tools are not intended to establish causal associations between medical products and potential adverse events. These approaches provide information about unexpected elevated frequencies of a health outcome after product exposure and should always be followed by clinical review and/or safety studies specifically designed to quantify the magnitude of effect with confounding control targeted at the specific outcome of interest.
Overview of Signal Identification Techniques Utilized by the Sentinel System
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