Book chapter
Active Surveillance: The United States Food and Drug Administration's Sentinel Initiative
Mann's Pharmacovigilance, pp.429-437
John Wiley & Sons, Ltd
04/01/2014
DOI: 10.1002/9781118820186.ch27
Abstract
The Sentinel Initiative is the active surveillance component of the postmarket safety surveillance system of the Food and Drug Administration (FDA). Mini‐Sentinel is a pilot program building the foundation for the Sentinel System. It is a collaboration between the FDA, academic institutions, and data partners that uses a distributed data system to allow analysis of data from health plans and other sources across a network of participating sites. This chapter provides an overview of the Sentinel Initiative, with a focus on Mini‐Sentinel.
Details
- Title: Subtitle
- Active Surveillance: The United States Food and Drug Administration's Sentinel Initiative
- Creators
- Ryan M Carnahan - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, USACarlos J Bell - Office of Medical Policy, Center for Drug Evaluation Research, US Food and Drug Administration, Silver Spring, MD, USA and US Public Health Service, Silver Spring, MD, USARichard Platt - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
- Contributors
- Elizabeth B Andrews (Editor) - Vice President, Pharmacoepidemiology and Risk Management, RTI Health Solutions, Research Triangle Park, NC, USANicholas Moore (Editor) - Professor of Clinical Pharmacology, Service Hospitalo‐Universitaire de Pharmacologie, Bordeaux, France
- Resource Type
- Book chapter
- Publication Details
- Mann's Pharmacovigilance, pp.429-437
- DOI
- 10.1002/9781118820186.ch27
- Publisher
- John Wiley & Sons, Ltd; Oxford, UK
- Number of pages
- 9
- Language
- English
- Date published
- 04/01/2014
- Academic Unit
- Epidemiology; Nursing; Injury Prevention Research Center
- Record Identifier
- 9984214712102771
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