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Literature DB >> 30883696

A Review of the Regulatory Framework for Initiation and Acceleration of Patient Access to Innovative Medical Products in Japan.

Shunsuke Matsushita¹, Keisuke Tachibana¹, Kiyohito Nakai², Shoji Sanada³, Masuo Kondoh¹.

Abstract

Entities: Species

Mesh：

Year: 2019 PMID： 30883696 DOI： 10.1002/cpt.1383

Source DB: PubMed Journal: Clin Pharmacol Ther ISSN： 0009-9236 Impact factor: 6.875

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2 in total

Review 1. Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval.

Authors: Shunsuke Matsushita; Keisuke Tachibana; Tetsuya Kusakabe; Ryuichi Hirayama; Yasuo Tsutsumi; Masuo Kondoh
Journal: Clin Transl Sci Date: 2021-04-03 Impact factor: 4.689

Review 2. A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior.

Authors: Nagomi Ota; Keisuke Tachibana; Tetsuya Kusakabe; Shoji Sanada; Masuo Kondoh
Journal: Clin Transl Sci Date: 2020-04-03 Impact factor: 4.689

2 in total