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瑞士药品管理局新指南详述抗癌药多国同步审批 Orbis... 2021.02.20

瑞士药品管理局(Swissmedic)已决定https//www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/swissmedic-beteiligt-permanent-projekt-orbis.html 长久参与 Orbis 计划(Project Orbis),这是一项全球计划,允许参与机构同时审评新的癌症药物。Swissmedic 最近...

抗癌药多国同步审批 Orbis 计划一周年概要数据 2020.12.10

最近《临床癌症研究》(Clinical Cancer Research)上发表了一篇监管科学和政策观点文章“Project Orbis Global Collaborative Review Program”1,介绍了 Orbis 计划过去一年的实施经验,作者是 Orbis 计划参与国监管机构的科学家们。 Orbis 计划(Project Orbis)于 201...

FDA批准治疗慢性淋巴细胞白血病的新疗法 2019.11.21

【FDA在国际合作下采取第二项行动,批准治疗慢性淋巴细胞白血病的新疗法】 For Immediate Release November 21, 2019 Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada, the U.S. Foo...

Project Orbis---FDA与多国合作加速肿瘤药物审批 2019.09.18

Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), provides a framework for concurrent submission and review of oncology products among international partners. Collaboration among international regulators may allow patients wi...

在与澳大利亚和加拿大的新国际合作中FDA首次采取行动... 2019.09.18

FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma For Immediate Release Septemb...