US Food and Drug Administration Sentinel Initiative and Postmarket Drug Safety Surveillance

This review observed that as FDA considers modernizing the Sentinel Initiative as part of forthcoming PDUFA reauthorization, opportunities exist to strengthen the use and impact of the ARIA system by creating a publicly available, centralized, and regularly updated database of safety concerns, establishing a complete record of ARIA system information, adopting standardized terminology, and further expanding data linkages beyond claims data.

Corresponding Author: Joshua D. Wallach, PhD, MS, Department of Epidemiology, Rollins School of Public Health, Emory University, 1518 Clifton Rd, Claudia Nance Rollins Building, Room 3033, Atlanta, GA 30322 (joshua.wallach@emory.edu).

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