The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction-Reference-Cited by-同舟云学术

The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction

Published:2012-01 Issue: Volume:21 Page:1-8
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Platt Richard¹,Carnahan Ryan M.²,Brown Jeffrey S.¹,Chrischilles Elizabeth²,Curtis Lesley H.³,Hennessy Sean⁴,Nelson Jennifer C.⁵,Racoosin Judith A.⁶,Robb Melissa⁶,Schneeweiss Sebastian⁷,Toh Sengwee¹,Weiner Mark G.⁸

Affiliation:

1. Department of Population Medicine; Harvard Medical School and Harvard Pilgrim Health Care Institute; Boston MA USA

2. Department of Epidemiology; College of Public Health; University of Iowa; Iowa City IA USA

3. Duke Clinical Research Institute and Department of Medicine; Duke University School of Medicine; Durham NC USA

4. Center for Clinical Epidemiology and Biostatistics; Perelman School of Medicine; University of Pennsylvania; Philadelphia PA USA

5. Biostatistics Unit; Group Health Research Institute; Seattle WA USA

6. Office of Medical Policy, Center for Drug Evaluation and Research; Food and Drug Administration; Silver Spring MD USA

7. Division of Pharmacoepidemiology and Pharmacoeconomics; Brigham and Women's Hospital and Harvard Medical School; Boston MA USA

8. Division of General Internal Medicine, Department of Medicine; Perelman School of Medicine, University of Pennsylvania; Philadelphia PA USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.2343/fullpdf

Reference43 articles.

1. Developing the Sentinel System--a national resource for evidence development;Behrman;N Engl J Med,2011

2. The new Sentinel Network--improving the evidence of medical-product safety;Platt;N Engl J Med,2009

3. The U.S. Food and Drug Administration's Mini-Sentinel Program: status and direction;Pharmacoepidemiol Drug Saf,2012

4. FDA's Sentinel Initiative: Expanding the horizons of medical product safety;Robb;Pharmacoepidemiol Drug Saf,2012

5. The Sentinel Initiative: Access to electronic healthcare data for more than 25 million lives: Achieving FDAAA Section 905 Goal One U.S. Food and Drug Administration 2010 http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM233360.pdf

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