Indian journal of medical ethics
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Indian J Med Ethics · Oct 2017
Observational StudyAccelerated approval of drugs: ethics versus efficacy.
To analyse the post-marketing status of molecules approved through the expedited review process in the last quintile. ⋯ Drug approval by accelerated review should be stringent. Beneficence and non-maleficence are applicable to the global population, and should apply equally to subjects involved in trials. Approving drugs on the basis of trivial evidence is non-scientific and absolutely unethical, since it can lead to clinical failure and produce serious adverse events.