Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools-Reference-Cited by-同舟云学术

Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools

Published:2018-02-02 Issue:3 Volume:27 Page:332-339
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Sobel Rachel E.¹^ORCID,Bate Andrew¹^ORCID,Marshall James²,Haynes Kevin³,Selvam Nandini³,Nair Vinit⁴,Daniel Gregory⁵,Brown Jeffrey S.²,Reynolds Robert F.¹

Affiliation:

1. Epidemiology/Worldwide Research and Development; Pfizer Inc; New York NY USA

2. Population Medicine; Harvard Medical School & Harvard Pilgrim Health Care Institute; Boston MA USA

3. HealthCore, Inc; Wilmington DE USA

4. Humana Inc; Louisville KY USA

5. Duke-Robert J. Margolis, MD Center for Health Policy; Duke University; Washington DC USA

Funder

Pfizer

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

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3. European Medicines Agency Good pharmacovigilance processes (EU GVP) module V http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf

4. European Medicines Agency Good pharmacovigilance processes (EU GVP) module XVI http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/02/WC500162051.pdf

5. Post-approval evaluation of effectiveness of risk minimisation: Methods, challenges and interpretation;Banerjee;Drug Saf,2014

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