目的：分析美国食品药品管理局（FDA）公共数据开放项目（openFDA）的启动背景、运行模式和管理经验，为我国食品药品监管数据管理工作提供参考。方法：采用文献研究的方法，对FDA政府网站有关专栏和openFDA项目网站以及在中国知网等数据库中检索到的文献资料进行分析研究。结果与结论：openFDA项目自开展以来积累了大量数据，采取提供应用程序接口、提供数据资料直接下载，以及建立开发者社区为其提供交流和分享的平台多种方式进行公共数据开放，并已取得了一定成效，值得思考借鉴。
Objective:To analyze the background, mode and management experience of openFDA, in order to provide references for the data management of food and drug administration in China. Methods:Relevant columns on FDA websites, openFDA project website, literatures found in the China National Knowledge Internet (CNKI) and other databases were analyzed using the method of literature analysis. Results and Conclusion:The openFDA project has accumulated a lot of data since its implementation and has provided several to improve the data opening of openFDA, including providing application interface, direct data download as well as establishing, a developer community to provide communication and sharing platform, and has been proved effective in practice, which is enlightenments for us.
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