首页> Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs> Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA's perspective.

Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA's perspective.

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第一作者： Nobuhiro,Handa

第一单位： Office of Medical Device, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan. handa-nobuhiro@pmda.go.jp.;Medical Device Unit, Pharmaceuticals and Medical Devices Agency, 3-3-2, Shin-Kasumigaseki Building 11F, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. handa-nobuhiro@pmda.go.jp.

作者： Nobuhiro,Handa ^[1] ; Shuichi,Mochizuki ^[2] ; Yasuhiro,Fujiwara ^[3] ; Masafumi,Shimokawa ^[4] ; Rika,Wakao ^[4] ; Hiroyuki,Arai ^[4]

作者单位： Office of Medical Device, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan. handa-nobuhiro@pmda.go.jp.;Medical Device Unit, Pharmaceuticals and Medical Devices Agency, 3-3-2, Shin-Kasumigaseki Building 11F, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. handa-nobuhiro@pmda.go.jp. ^[1] Office of Medical Device, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan. ^[2] Office of Regenerative Medicine, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan. ^[3] Regulatory Science Center, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan. ^[4]

关键词 Cutting edge new technology Horizon scanning PMDA Regulatory review Science board

医学主题词人工智能(Artificial Intelligence);人工器官(Artificial Organs);生物技术(Biotechnology);设备批准(Device Approval);药物批准(Drug Approval);人类(Humans);日本(Japan)

DOI 10.1007/s10047-020-01161-4

PMID 32112156

发布时间 2021-02-09

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准确一般字义偏差语意偏离译文作用小提交