A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report.

@article{Psaty2012ALA,
  title={A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report.},
  author={Bruce M. Psaty and Eric M. Meslin and Alasdair M. Breckenridge},
  journal={JAMA},
  year={2012},
  volume={307 23},
  pages={2491-2}
}
IN THE POSTMARKET SETTING,THE REGULATION OF MEDICINES requires an assessment of the balance between their benefits and risks and, as new information becomes available, may require regulatory actions that range from changes in the product label to withdrawal of a drug from the market. A series of unforeseen consequences of drug administration to vulnerablepatientshas shaped themodernhistoryof the regulation of medications. In the 1960s, for instance, thalidomide given to pregnant women resulted… CONTINUE READING
Recent Discussions
This paper has been referenced on Twitter 7 times over the past 90 days. VIEW TWEETS
16 Citations
3 References
Similar Papers

Citations

Publications citing this paper.
Showing 1-10 of 16 extracted citations

References

Publications referenced by this paper.

Similar Papers

Loading similar papers…