FDA 医疗器械真实世界证据监管指南更新解读及对我国的启示
刘晴, 胡莎, 袁玮鸿, 程欢莲, 刘羽, 彭琳, 曾治宇
Updated FDA Regulatory Guidance on Real-World Evidence for Medical Devices: Interpretation and Implications for China
LIU Qing, HU Sha, YUAN Wei-hong, CHENG Huan-lian, LIU Yu, PENG Lin, ZENG Zhi-yu
中国食品药品监管
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2026, (10): 76
-87
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DOI: 10.3969/j.issn.1673-5390.2026.10.008
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