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Trend Analysis of Regulatory Approval Pathways and Major Shifts in Pivotal Clinical Trial Designs for Antineoplastic Drugs Approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) From 2004 to 2019.

2021-07-26

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<title>Abstract</title> <p>BackgroundThe Japanese Pharmaceuticals and Medical Devices Agency (PMDA) was established in 2004. Since then, various pieces of legislation, notices, and guidelines have been issued, and the regulatory approval pathways for domestic drugs have been diversified. However, the effects of these measures have not been fully examined. We examined the impact of these measures on the approval o...

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Literature Corpus work: d388aff9-a1c5-5291-b6a4-8f001051eb23
DOI: 10.21203/rs.3.rs-630019/v1

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Trend Analysis of Regulatory Approval Pathways and Major Shifts in Pivotal Clinical Trial Designs for Antineoplastic Drugs Approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) From 2004 to 2019.DOI 10.21203/rs.3.rs-630019/v1Read

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