Literature DB >> 24443478

Assessment of US pathway for approving medical devices for rare conditions.

Thomas J Hwang1, Daniel Carpenter, Aaron S Kesselheim.   

Abstract

Mesh:

Year:  2014        PMID: 24443478     DOI: 10.1136/bmj.g217

Source DB:  PubMed          Journal:  BMJ        ISSN: 0959-8138


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  6 in total

1.  Medical device postapproval safety monitoring: where does the United States stand?

Authors:  Prashant V Rajan; Daniel B Kramer; Aaron S Kesselheim
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2015-01-06

2.  Postmarketing trials and pediatric device approvals.

Authors:  Thomas J Hwang; Aaron S Kesselheim; Florence T Bourgeois
Journal:  Pediatrics       Date:  2014-04-14       Impact factor: 7.124

3.  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

4.  Characteristics of pivotal trials and FDA review of innovative devices.

Authors:  Joshua P Rising; Ben Moscovitch
Journal:  PLoS One       Date:  2015-02-04       Impact factor: 3.240

5.  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

6.  Orphan devices: yesterday is history; tomorrow is mystery: towards a European orphan device directive?

Authors:  Marc M Dooms
Journal:  Orphanet J Rare Dis       Date:  2016-03-03       Impact factor: 4.123

  6 in total

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