Literature DB >> 18430914

FDA guidance on off-label promotion and the state of the literature from sponsors.

Bruce M Psaty1, Wayne Ray.   

Abstract

Mesh：

Year:  2008        PMID： 18430914     DOI： 10.1001/jama.299.16.1949

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


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  8 in total

1.  Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings.

Authors:  Daniel M Cook; Rama K Gurugubelli; Lisa A Bero
Journal:  Drug Saf       Date:  2009       Impact factor: 5.606

2.  Off-label drug information: regulation, distribution, evaluation, and related controversies.

Authors:  C Lee Ventola
Journal:  P T       Date:  2009-08

3.  Off-label prescribing: a call for heightened professional and government oversight.

Authors:  Rebecca Dresser; Joel Frader
Journal:  J Law Med Ethics       Date:  2009       Impact factor: 1.718

4.  Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints.

Authors:  Aaron S Kesselheim; Michelle M Mello; David M Studdert
Journal:  PLoS Med       Date:  2011-04-05       Impact factor: 11.069

5.  Patient-reported outcomes as a source of evidence in off-label prescribing: analysis of data from PatientsLikeMe.

Authors:  Jeana Frost; Sally Okun; Timothy Vaughan; James Heywood; Paul Wicks
Journal:  J Med Internet Res       Date:  2011-01-21       Impact factor: 5.428

6.  Off-label use of medicines in children: can available evidence avoid useless paediatric trials? The case of proton pump inhibitors for the treatment of gastroesophageal reflux disease.

Authors:  Giovanni Tafuri; Francesco Trotta; Hubert G M Leufkens; Nello Martini; Luciano Sagliocca; Giuseppe Traversa
Journal:  Eur J Clin Pharmacol       Date:  2008-09-17       Impact factor: 2.953

7.  Pharmacotherapy of schizophrenic patients: preponderance of off-label drug use.

Authors:  David Pickar; Jessie Vinik; John J Bartko
Journal:  PLoS One       Date:  2008-09-10       Impact factor: 3.240

8.  Development and evaluation of an ensemble resource linking medications to their indications.

Authors:  Wei-Qi Wei; Robert M Cronin; Hua Xu; Thomas A Lasko; Lisa Bastarache; Joshua C Denny
Journal:  J Am Med Inform Assoc       Date:  2013-04-10       Impact factor: 4.497
  8 in total

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