Literature DB >> 22563032

A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report.

Bruce M Psaty1, Eric M Meslin, Alasdair Breckenridge.   

Abstract

Mesh:

Year:  2012        PMID: 22563032     DOI: 10.1001/jama.2012.5545

Source DB:  PubMed          Journal:  JAMA        ISSN: 0098-7484            Impact factor:   56.272


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  18 in total

1.  Industry Support of Medical Research: Important Opportunity or Treacherous Pitfall?

Authors:  William M Tierney; Eric M Meslin; Kurt Kroenke
Journal:  J Gen Intern Med       Date:  2015-08-26       Impact factor: 5.128

2.  Timeliness of Postmarket Studies for New Pharmaceuticals Approved Between 2009 and 2012: a Cross-Sectional Analysis.

Authors:  Joshua D Wallach; Alexander C Egilman; Joseph S Ross; Steven Woloshin; Lisa M Schwartz
Journal:  J Gen Intern Med       Date:  2019-04       Impact factor: 5.128

3.  Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act.

Authors:  Thomas J Hwang; Liat Orenstein; Aaron S Kesselheim; Florence T Bourgeois
Journal:  JAMA Pediatr       Date:  2019-01-01       Impact factor: 16.193

4.  Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.

Authors:  Nicholas S Downing; Jenerius A Aminawung; Nilay D Shah; Harlan M Krumholz; Joseph S Ross
Journal:  JAMA       Date:  2014 Jan 22-29       Impact factor: 56.272

Review 5.  FDA Policy and Cardiovascular Medicine.

Authors:  Joseph S Ross; Aaron S Kesselheim
Journal:  Circulation       Date:  2015-09-22       Impact factor: 29.690

6.  Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis.

Authors:  Krista Y Chen; Erin M Borglund; Emma Charlotte Postema; Adam G Dunn; Florence T Bourgeois
Journal:  Clin Trials       Date:  2022-04-28       Impact factor: 2.599

7.  US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.

Authors:  Joshua J Skydel; Audrey D Zhang; Sanket S Dhruva; Joseph S Ross; Joshua D Wallach
Journal:  Clin Trials       Date:  2021-04-16       Impact factor: 2.486

8.  Inconsistencies among European Union pharmaceutical regulator safety communications: a cross-country comparison.

Authors:  Jean-David Zeitoun; Jérémie H Lefèvre; Nicholas Downing; Henri Bergeron; Joseph S Ross
Journal:  PLoS One       Date:  2014-10-21       Impact factor: 3.240

9.  A new approach to psychiatric drug approval in Europe.

Authors:  Corrado Barbui; Irene Bighelli
Journal:  PLoS Med       Date:  2013-10-15       Impact factor: 11.069

Review 10.  Risk evaluation and monitoring in multiple sclerosis therapeutics.

Authors:  Michel C Clanet; Jerry S Wolinsky; Raymond J Ashton; Hans-Peter Hartung; Stephen C Reingold
Journal:  Mult Scler       Date:  2013-11-30       Impact factor: 6.312

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