Literature DB >> 26902933

Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study.

Adam T Phillips1, Vinay K Rathi2, Joseph S Ross3.   

Abstract

Mesh：

Year:  2016        PMID： 26902933     DOI： 10.1001/jamainternmed.2015.8590

Source DB:  PubMed          Journal:  JAMA Intern Med        ISSN： 2168-6106            Impact factor:   21.873


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  3 in total

1.  Transparency and Dermatologic Device Approval by the US Food and Drug Administration.

Authors:  Harib H Ezaldein; Jeffrey F Scott; Emily S Yin; Alessandra Ventura; Nicholaas P DeRuyter; David J Leffell
Journal:  JAMA Dermatol       Date:  2018-03-01       Impact factor: 10.282

2.  Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA.

Authors:  Matthew J Swanson; James L Johnston; Joseph S Ross
Journal:  Trials       Date:  2021-11-17       Impact factor: 2.728

Review 3.  Association of the FDA Amendment Act with trial registration, publication, and outcome reporting.

Authors:  Adam T Phillips; Nihar R Desai; Harlan M Krumholz; Constance X Zou; Jennifer E Miller; Joseph S Ross
Journal:  Trials       Date:  2017-07-18       Impact factor: 2.279
  3 in total

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