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2018 财年 GDUFA 科学与研究成果 2019.10.04

Each year, FDA prepares annual reports on the science and research-funded projects conducted under the Generic Drug User Fee Amendments of 2017 (GDUFA II) regulatory science program. These reports provide greater transparency regarding the important w...

FDA - TCPro 工具模拟生物治疗药物免疫应答 2019.09.18

Scientists at the U.S. Food and Drug Administration (FDA) have developed a mathematical tool that predicts whether the body will produce antibodies that block the activity of biotherapeutic protein drugs. The computational tool, called TCPro, simula...

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 wit...

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 Septembe...