Literature DB >> 28505214

Publication and Reporting of the Results of Postmarket Studies for Drugs Required by the US Food and Drug Administration, 2009 to 2013.

Marisa L Cruz1, Jing Xu1, Mwango Kashoki2, Peter Lurie1.   

Abstract

Mesh：

Year:  2017        PMID： 28505214      PMCID： PMC5818792          DOI： 10.1001/jamainternmed.2017.1313

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


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  2 in total

1.  Availability and Dissemination of Results From US Food and Drug Administration-Mandated Postapproval Studies for Medical Devices.

Authors:  Odayme Quesada; Erin Yang; Rita F Redberg
Journal:  JAMA Intern Med       Date:  2016-08-01       Impact factor: 21.873

2.  Publication of pivotal efficacy trials for novel therapeutic agents approved between 2005 and 2011: a cross-sectional study.

Authors:  James W Smithy; Nicholas S Downing; Joseph S Ross
Journal:  JAMA Intern Med       Date:  2014-09       Impact factor: 21.873
  2 in total
  8 in total

1.  Using Human 'Experiments of Nature' to Predict Drug Safety Issues: An Example with PCSK9 Inhibitors.

Authors:  Rebecca N Jerome; Jill M Pulley; Dan M Roden; Jana K Shirey-Rice; Lisa A Bastarache; Gordon R Bernard; Leeland B Ekstrom; William J Lancaster; Joshua C Denny
Journal:  Drug Saf       Date:  2018-03       Impact factor: 5.606

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.  Real-World Evidence: Promise and Peril For Medical Product Evaluation.

Authors:  Sanket S Dhruva; Joseph S Ross; Nihar R Desai
Journal:  P T       Date:  2018-08

5.  New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.

Authors:  Osman Moneer; Beatrice L Brown; Jerry Avorn; Jonathan J Darrow; Mayookha Mitra-Majumdar; Krysten W Joyce; Murray Ross; Catherine Pham; Aaron S Kesselheim
Journal:  Drug Saf       Date:  2022-02-19       Impact factor: 5.228

6.  Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis.

Authors:  Joshua D Wallach; Alexander C Egilman; Sanket S Dhruva; Margaret E McCarthy; Jennifer E Miller; Steven Woloshin; Lisa M Schwartz; Joseph S Ross
Journal:  BMJ       Date:  2018-05-24

7.  Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis.

Authors:  Joshua D Wallach; Anita T Luxkaranayagam; Sanket S Dhruva; Jennifer E Miller; Joseph S Ross
Journal:  BMC Med       Date:  2019-06-17       Impact factor: 8.775

8.  Clinical trial registration and reporting: a survey of academic organizations in the United States.

Authors:  Evan Mayo-Wilson; James Heyward; Anthony Keyes; Jesse Reynolds; Sarah White; Nidhi Atri; G Caleb Alexander; Audrey Omar; Daniel E Ford
Journal:  BMC Med       Date:  2018-05-02       Impact factor: 8.775
  8 in total

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