November 28, 2018

The FDA Sentinel Initiative — An Evolving National Resource

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Abstract

A decade after the launch of the FDA Sentinel Initiative, it has matured from a pilot program designed to assess potential drug-safety signals in insurance claims into a core component of the agency’s evolving safety surveillance system.

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Authors

Richard Platt

Harvard University

Jeffrey S. Brown

AstraZeneca (United Kingdom)

Melissa A. Robb

United States Food and Drug Administration

Journals

New England Journal of Medicine

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Institutions

Harvard University

United States Food and Drug Administration

Harvard Pilgrim Health Care

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Platt et al. (Wed,) studied this question.

synapsesocial.com/papers/69df47a7d5404a0bea592cae — DOI: https://doi.org/10.1056/nejmp1809643

Also consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

The FDA's sentinel initiative—A comprehensive approach to medical product surveillance· 2015 · 248 citations
Developing the Sentinel System — A National Resource for Evidence Development· 2011 · 328 citations
The New Sentinel Network — Improving the Evidence of Medical-Product Safety· 2009 · 231 citations
Distributed Health Data Networks· 2010 · 218 citations
Mini-Sentinel and Regulatory Science — Big Data Rendered Fit and Functional· 2014 · 91 citations

Also consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

The FDA's sentinel initiative—A comprehensive approach to medical product surveillance· 2015 · 248 citations
Developing the Sentinel System — A National Resource for Evidence Development· 2011 · 328 citations
The New Sentinel Network — Improving the Evidence of Medical-Product Safety· 2009 · 231 citations
Distributed Health Data Networks· 2010 · 218 citations
Mini-Sentinel and Regulatory Science — Big Data Rendered Fit and Functional· 2014 · 91 citations

The FDA Sentinel Initiative — An Evolving National Resource

Key Points

Abstract

Citation Network

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Discussion

Authors

Journals

Actions

Institutions

References and Citations

Citation Network

Connected Papers

Discussion

Cite this study

Also consider

Also consider