Premarketing studies in the drug approval process: understanding their limitations regarding the assessment of drug safety.

@article{Laughren1998PremarketingSI,
  title={Premarketing studies in the drug approval process: understanding their limitations regarding the assessment of drug safety.},
  author={Thomas P. Laughren},
  journal={Clinical therapeutics},
  year={1998},
  volume={20 Suppl C},
  pages={C12-9}
}
This paper discusses the premarketing safety database that the US Food and Drug Administration receives from drug manufacturers. It reviews the kind of data we usually receive, what we do with the data, and how the data affect labeling. In addition, it discusses some of the limitations of that database in ensuring the safe use of medications.