Literature DB >> 12487336

Making "me-too" drugs benefit the public.

Neil J Nusbaum1.   

Abstract

The Food and Drug Administration (FDA), in its review of pharmaceuticals for safety and effectiveness, has relied heavily on placebo-controlled studies. In their prescribing practice, physicians often face clinical decisions between several FDA-approved drugs for the same indication, with little guidance from the FDA on the similarities or differences of the drugs. The public could benefit if the FDA were more proactive in declaring, when applicable, that the best available evidence does not indicate any significant clinical advantage for a particular FDA-approved drug compared with others.

Mesh:

Year:  2002        PMID: 12487336     DOI: 10.1177/106286060201700603

Source DB:  PubMed          Journal:  Am J Med Qual        ISSN: 1062-8606            Impact factor:   1.852


  1 in total

1.  The ethics of placebo-controlled trials: methodological justifications.

Authors:  Joseph Millum; Christine Grady
Journal:  Contemp Clin Trials       Date:  2013-09-12       Impact factor: 2.226

  1 in total

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