Literature DB >> 18596282

Drug-review deadlines and safety problems.

Clark Nardinelli, Michael Lanthier, Robert Temple.   

Abstract

Mesh：

Year:  2008        PMID： 18596282     DOI： 10.1056/NEJMc086158

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


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  3 in total

1.  Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.

Authors:  S Sekine; E E Pinnow; E Wu; R Kurtzig; M Hall; G J Dal Pan
Journal:  Clin Pharmacol Ther       Date:  2016-03-31       Impact factor: 6.875

2.  Why we need easy access to all data from all clinical trials and how to accomplish it.

Authors:  Peter C Gøtzsche
Journal:  Trials       Date:  2011-11-23       Impact factor: 2.279

3.  Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study.

Authors:  Sana R Mostaghim; Joshua J Gagne; Aaron S Kesselheim
Journal:  BMJ       Date:  2017-09-07
  3 in total

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