A critical review of methods to evaluate the impact of FDA regulatory actions-Reference-Cited by-同舟云学术

A critical review of methods to evaluate the impact of FDA regulatory actions

Published:2013-07-12 Issue:9 Volume:22 Page:986-994
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Briesacher Becky A.¹²,Soumerai Stephen B.³,Zhang Fang³,Toh Sengwee³,Andrade Susan E.¹²,Wagner Joann L.²,Shoaibi Azadeh⁴,Gurwitz Jerry H.¹²

Affiliation:

1. Division of Geriatric Medicine; University of Massachusetts Medical School; Worcester MA USA

2. Meyers Primary Care Institute, a joint endeavor of Fallon Community Health Plan; Reliant Medical Group and the University of Massachusetts Medical School; Worcester MA USA

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

4. Center for Drug Evaluation and Research; U.S. Food and Drug Administration; Silver Spring MD USA

Funder

FDA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.3480/fullpdf

Reference46 articles.

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2. U.S. Food and Drug Administration Guidance drug safety information-FDA's communication to the public 2012 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072281.pdf

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

4. The US Food and Drug Administration's Sentinel Initiative: expanding the horizons of medical product safety;Robb;Pharmacoepidemiol Drug Saf,2012

5. Design considerations, architecture, and use of the Mini-Sentinel distributed data system;Curtis;Pharmacoepidemiol Drug Saf,2012

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