Literature DB >> 17435081

Drug safety reform at the FDA--pendulum swing or systematic improvement?

Mark McClellan1.   

Abstract

Mesh:

Year:  2007        PMID: 17435081     DOI: 10.1056/NEJMp078057

Source DB:  PubMed          Journal:  N Engl J Med        ISSN: 0028-4793            Impact factor:   91.245


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  20 in total

1.  Predicting adverse drug events from personal health messages.

Authors:  Brant W Chee; Richard Berlin; Bruce Schatz
Journal:  AMIA Annu Symp Proc       Date:  2011-10-22

2.  Preemption, tort reform, and pharmaceutical claims: Part two: Has the Food and Drug Administration shown it is solely responsible for the protection of patients? Can it do so? Will it do so?

Authors:  Russell G Thornton
Journal:  Proc (Bayl Univ Med Cent)       Date:  2008-01

3.  What should an ideal vaccine postlicensure safety system be?

Authors:  Marie R Griffin; M Miles Braun; Kenneth J Bart
Journal:  Am J Public Health       Date:  2009-10       Impact factor: 9.308

4.  To establish a body of evidence on safety for postmarketing Chinese medicine: A new research paradigm.

Authors:  Xing Liao; Yan-Ming Xie; Nicola Robinson; Yong-Yan Wang
Journal:  Chin J Integr Med       Date:  2016-11-29       Impact factor: 1.978

5.  Combing signals from spontaneous reports and electronic health records for detection of adverse drug reactions.

Authors:  Rave Harpaz; Santiago Vilar; William Dumouchel; Hojjat Salmasian; Krystl Haerian; Nigam H Shah; Herbert S Chase; Carol Friedman
Journal:  J Am Med Inform Assoc       Date:  2012-10-31       Impact factor: 4.497

Review 6.  Active pharmacovigilance in China: recent development and future perspectives.

Authors:  Xinling Li; Haona Li; Jianxiong Deng; Feng Zhu; Ying Liu; Wenge Chen; Zhihua Yue; Xuequn Ren; Jielai Xia
Journal:  Eur J Clin Pharmacol       Date:  2018-04-10       Impact factor: 2.953

7.  Data quality assessment for comparative effectiveness research in distributed data networks.

Authors:  Jeffrey S Brown; Michael Kahn; Sengwee Toh
Journal:  Med Care       Date:  2013-08       Impact factor: 2.983

8.  Are adult patients more tolerant of treatment risks than parents of juvenile patients?

Authors:  F Reed Johnson; Semra Ozdemir; Carol Mansfield; Steven Hass; Corey A Siegel; Bruce E Sands
Journal:  Risk Anal       Date:  2008-09-26       Impact factor: 4.000

Review 9.  Pharmacovigilance: methods, recent developments and future perspectives.

Authors:  L Härmark; A C van Grootheest
Journal:  Eur J Clin Pharmacol       Date:  2008-06-04       Impact factor: 2.953

10.  Beyond post-marketing research and MedWatch: Long-term studies of drug risks.

Authors:  David B Resnik
Journal:  Drug Des Devel Ther       Date:  2007-10-01       Impact factor: 4.162

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