Literature DB >> 24597559

Regulatory reticence and medical devices.

Daniel M Fox1, Diana M Zuckerman.   

Abstract

Mesh:

Year:  2014        PMID: 24597559      PMCID: PMC3955381          DOI: 10.1111/1468-0009.12044

Source DB:  PubMed          Journal:  Milbank Q        ISSN: 0887-378X            Impact factor:   4.911


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  7 in total

1.  The consequence of secret prices: the politics of physician preference items.

Authors:  Jeffrey C Lerner; Daniel M Fox; Todd Nelson; John B Reiss
Journal:  Health Aff (Millwood)       Date:  2008 Nov-Dec       Impact factor: 6.301

2.  FDA recalls not as alarming as they seem.

Authors:  Jason T Connor; Roger J Lewis; Donald A Berry; Scott M Berry
Journal:  Arch Intern Med       Date:  2011-06-13

3.  Public health implications of differences in U.S. and European Union regulatory policies for breast implants.

Authors:  Diana Zuckerman; Nyedra Booker; Sonia Nagda
Journal:  Reprod Health Matters       Date:  2012-12

4.  Improving medical device regulation: the United States and Europe in perspective.

Authors:  Corinna Sorenson; Michael Drummond
Journal:  Milbank Q       Date:  2014-03       Impact factor: 4.911

5.  FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

Authors:  Benjamin N Rome; Daniel B Kramer; Aaron S Kesselheim
Journal:  JAMA       Date:  2014 Jan 22-29       Impact factor: 56.272

6.  Medical device recalls and the FDA approval process.

Authors:  Diana M Zuckerman; Paul Brown; Steven E Nissen
Journal:  Arch Intern Med       Date:  2011-02-14

Review 7.  How does medical device regulation perform in the United States and the European union? A systematic review.

Authors:  Daniel B Kramer; Shuai Xu; Aaron S Kesselheim
Journal:  PLoS Med       Date:  2012-07-31       Impact factor: 11.069

  7 in total
  2 in total

1.  Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012.

Authors:  Jenny Hwang; Thomas J Hwang; Joseph B Ciolino
Journal:  BMJ Open       Date:  2015-06-04       Impact factor: 2.692

2.  Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study.

Authors:  Thomas J Hwang; Elisaveta Sokolov; Jessica M Franklin; Aaron S Kesselheim
Journal:  BMJ       Date:  2016-06-28
  2 in total

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