A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs

@article{Zeukeng2018ACO,
  title={A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs},
  author={Minette-Jo{\"e}lle Zeukeng and Enrique Seoane-Vazquez and Pascal Bonnabry},
  journal={European Journal of Clinical Pharmacology},
  year={2018},
  volume={74},
  pages={811-818}
}
This study compared the characteristics of new human drugs approved by the Food and Drug Administration (FDA), the European Medicine Agency (EMA), and Swissmedic (SMC) in the period 2007 to 2016. The list of new drugs and therapeutic biologics approved by the FDA, the EMA, and SMC in the period 2007 to 2016 was collected from websites of those agencies. The study included regulatory information, approval date, and indication for each drug. Descriptive statistical t tests and x2-tests were… CONTINUE READING