How Often Are Drugs Made Available Under the Food and Drug Administration's Expanded Access Process Approved?

@article{McKee2017HowOA,
  title={How Often Are Drugs Made Available Under the Food and Drug Administration's Expanded Access Process Approved?},
  author={Amy McKee and Andr{\'e} O Markon and Kirk Maurice Chan-Tack and Peter G Lurie},
  journal={Journal of clinical pharmacology},
  year={2017},
  volume={57 Suppl 10},
  pages={S136-S142}
}
In this review of individual patient expanded-access requests to the Center for Drug Evaluation and Research for the period Fiscal Year 2010 to Fiscal Year 2014, we evaluated the number of applications received and the number allowed to proceed. We also evaluated whether drugs and certain biologics obtained under expanded access went on to be approved by… CONTINUE READING