美国FDA医疗器械监管数字化转型的进展分析及eSTAR模板的应用
沈海南, 侯艳, 丁金聚, 张译丹, 刘斌
Analysis of the Progress in Digital Transformation of Medical Device Regulation by the FDA and the Application of the Medical Device Electronic Submission Template and Resource (eSTAR)
Shen Hainan, Hou Yan, Ding Jinju, Zhang Yidan, Liu Bin
中国药事
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2024, (5): 603
-610
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DOI: 10.16153/j.1002-7777.2024.05.013
