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Achievements and challenges of the Sakigake designation system in Japan

Mototsugu Tanaka1, Mayumi Idei1, Hiroshi Sakaguchi1

  • 1Office of New Drug 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

British Journal of Clinical Pharmacology
|March 11, 2021
PubMed

Keywords:
PRIMEapproval timebreakthrough therapydrug developmentregulatory approval, regulatory science

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