Matched analysis on orphan drug designations and approvals: cross regional analysis in the United States, the European Union, and Japan.

@article{Murakami2016MatchedAO,
  title={Matched analysis on orphan drug designations and approvals: cross regional analysis in the United States, the European Union, and Japan.},
  author={Manabu Murakami and Mamoru Narukawa},
  journal={Drug discovery today},
  year={2016},
  volume={21 4},
  pages={544-9}
}
Orphan drugs have become a key area of focus in drug development for resolving unmet medical needs. The Orphan Drug Act in the USA and similar legislation in Japan, the European Union (EU), and several other countries has been enacted since 1983. This study provides a quantitative review of all orphan drug designations and approvals since the implementation of orphan drug legislation in key three regions. This study also identified and reviewed 'commonly designated' drugs across regions. Out of… CONTINUE READING
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