Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study.

@article{Shetty2015AnalysisOW,
  title={Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study.},
  author={Yashashri Chandrakant Shetty and Aafreen A. Saiyed},
  journal={Journal of medical ethics},
  year={2015},
  volume={41 5},
  pages={398-403}
}
The US Food and Drug Administration (FDA) issues warning letters to all research stakeholders if unacceptable deficiencies are found during site visits. Warning letters issued by the FDA between January 2011 and December 2012 to clinical investigators and institutional review boards (IRBs) were reviewed for various violation themes and compared to similar… CONTINUE READING