Literature DB >> 29789869

The race for drug approvals: hasten slowly?

Alain Braillon1.   

Abstract

Keywords:  Accelerated approval; EMA; FDA; Harm-benefit; Market withdrawal; SMC; Surrogate

Mesh：

Year:  2018        PMID： 29789869     DOI： 10.1007/s00228-018-2490-9

Source DB:  PubMed          Journal:  Eur J Clin Pharmacol        ISSN： 0031-6970            Impact factor:   2.953


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  7 in total

1.  Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals.

Authors:  Chul Kim; Vinay Prasad
Journal:  JAMA Intern Med       Date:  2015-12       Impact factor: 21.873

Review 2.  Accelerated approval of oncology products: the food and drug administration experience.

Authors:  John R Johnson; Yang-Min Ning; Ann Farrell; Robert Justice; Patricia Keegan; Richard Pazdur
Journal:  J Natl Cancer Inst       Date:  2011-03-21       Impact factor: 13.506

3.  The withdrawal of drugs for commercial reasons: the incomplete story of tositumomab.

Authors:  Vinay Prasad
Journal:  JAMA Intern Med       Date:  2014-12       Impact factor: 21.873

4.  Ten years too long: strontium ranelate, cardiac events, and the European Medicines Agency.

Authors:  Mark J Bolland; Andrew Grey
Journal:  BMJ       Date:  2016-09-30

5.  Surrogate outcomes in clinical trials: a cautionary tale.

Authors:  Staffan Svensson; David B Menkes; Joel Lexchin
Journal:  JAMA Intern Med       Date:  2013-04-22       Impact factor: 21.873

6.  A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.

Authors:  Minette-Joëlle Zeukeng; Enrique Seoane-Vazquez; Pascal Bonnabry
Journal:  Eur J Clin Pharmacol       Date:  2018-02-22       Impact factor: 2.953

7.  Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis.

Authors:  Igho J Onakpoya; Carl J Heneghan; Jeffrey K Aronson
Journal:  BMC Med       Date:  2015-02-05       Impact factor: 8.775
  7 in total
  1 in total

1.  Response to the letter to the Editor regarding Zeukeng et al.'s article A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.

Authors:  Minette-Joëlle Zeukeng; Enrique Seoane-Vazquez; Pascal Bonnabry
Journal:  Eur J Clin Pharmacol       Date:  2018-05-26       Impact factor: 2.953
  1 in total

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