美國(guó)食品藥品管理局（FDA）在聚焦臨床需求的監(jiān)管理念和策略的實(shí)踐中，不斷調(diào)整修正監(jiān)管在法規(guī)和措施上不適應(yīng)，對(duì)我國(guó)完善藥品監(jiān)管制度有借鑒價(jià)值。采用文獻(xiàn)研究法，通過(guò)查找相關(guān)文獻(xiàn)以及FDA網(wǎng)站發(fā)布的一些信息和數(shù)據(jù)以及專家訪談，研究分析產(chǎn)品的臨床治療特點(diǎn)和審評(píng)審批歷程，并就其存在的現(xiàn)象進(jìn)行思考，旨在分析心血管疾病治療藥物鹽酸米多君片在美國(guó)獲得加快審評(píng)審批、上市、撤市、再次批準(zhǔn)上市等全過(guò)程，探討FDA聚焦臨床需求的風(fēng)險(xiǎn)-獲益平衡的藥品監(jiān)管理念及相關(guān)策略和措施，以期對(duì)我國(guó)藥品審評(píng)審批的理念調(diào)整和監(jiān)管制度的完善提供借鑒。

In the practice of monitoring concepts and strategies that focus on clinical needs, the FDA constantly adjusts and modifies regulatory oversight in terms of regulations and measures, which has the value for the reference to improve drug regulatory system in China such as review and approval. The literature research method was adopted in this article. The characteristics of clinical treatment of the products were analyzed based on the search for relevant literatures and some information, data published by the FDA website, and interviews with experts to review the evaluation process and reflect on its existing phenomena. The purpose of this article was to comb, analyze, and research the whole process of accelerating the approval, review, listing, withdrawal, and re-approval of the market for the treatment of cardio-vascular diseases such as midodrine hydrochloride in the United States, and to discuss the risk of the FDA focusing on clinical risk-benefit balanced pharmaceutical supervision concepts and related strategies and measures, with a view to providing reference for the adjustment of the concept of China's drug review approval and the improvement of the regulatory system.