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Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval

For drugs that are intended to fill unmet medical needs, such as the treatment of rare diseases or a subtype of cancer, it can take a long time to conduct confirmatory clinical trials due to limited patient availability. Delayed access to these drugs increases the risk of mortality of patients with...

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Publicat a:Clin Transl Sci
Autors principals: Matsushita, Shunsuke, Tachibana, Keisuke, Kusakabe, Tetsuya, Hirayama, Ryuichi, Tsutsumi, Yasuo, Kondoh, Masuo
Format: Artigo
Idioma:Inglês
Publicat: John Wiley and Sons Inc. 2021
Matèries:
Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC8212755/
https://ncbi.nlm.nih.gov/pubmed/33048440
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/cts.12898
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