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Drugs with FDA accelerated approval often have weak evidence, study finds

BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2905 (Published 14 June 2017) Cite this as: BMJ 2017;357:j2905
  1. Owen Dyer
  1. Montreal

Drugs that receive accelerated approvals from the US Food and Drug Administration often rest on a flawed evidence base, says research that evaluated over 7000 clinical studies conducted on 37 drugs that were given such approvals from 2000 to 2013.

The review, which also included researchers from the University of Pennsylvania and Stanford University, appeared in the US …

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