Literature DB >> 20484392

Transparency at the Food and Drug Administration.

Afia K Asamoah1, Joshua M Sharfstein.   

Abstract

Mesh:

Year:  2010        PMID: 20484392     DOI: 10.1056/NEJMp1005202

Source DB:  PubMed          Journal:  N Engl J Med        ISSN: 0028-4793            Impact factor:   91.245


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  7 in total

1.  Disclosure of grounds of European withdrawn and refused applications: a step forward on regulatory transparency.

Authors:  Giovanni Tafuri; Francesco Trotta; Hubert G M Leufkens; Luca Pani
Journal:  Br J Clin Pharmacol       Date:  2013-04       Impact factor: 4.335

2.  FDA regulation of cardiovascular devices and opportunities for improvement.

Authors:  Sanket S Dhruva; Rita F Redberg
Journal:  J Interv Card Electrophysiol       Date:  2012-12-21       Impact factor: 1.900

Review 3.  Publication bias, with a focus on psychiatry: causes and solutions.

Authors:  Erick H Turner
Journal:  CNS Drugs       Date:  2013-06       Impact factor: 5.749

4.  Publication bias in antipsychotic trials: an analysis of efficacy comparing the published literature to the US Food and Drug Administration database.

Authors:  Erick H Turner; Daniel Knoepflmacher; Lee Shapley
Journal:  PLoS Med       Date:  2012-03-20       Impact factor: 11.069

5.  Against vaccine assay secrecy.

Authors:  Matthew Herder; Todd F Hatchette; Scott A Halperin; Joanne M Langley
Journal:  Hum Vaccin Immunother       Date:  2015       Impact factor: 3.452

6.  Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA).

Authors:  Ana Cerúlia Moraes do Carmo; Stefânia Schimaneski Piras; Nayrton Flávio Moura Rocha; Tais Gratieri
Journal:  Biomed Res Int       Date:  2017-02-09       Impact factor: 3.411

7.  The "Transparency for Safety" Triangle: Developing a Smart Transparency Framework to Achieve a Safety Learning Community.

Authors:  Paul Lindhout; Genserik Reniers
Journal:  Int J Environ Res Public Health       Date:  2022-09-23       Impact factor: 4.614

  7 in total

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