【摘要】 文中对美国FDA新药上市后临床试验及研究的管理体系以及法律法规进行了研究分析,期望对我国新药Ⅳ期临床试验管理以及全生命周期研究评价模式建设有参考和借鉴作用。更多还原

【Abstract】 The management system of postmarketing clinical trial and study,and the relative regulations of America Food and Drug Administration were analyzed.The purpose is to draw some experiences as reference to the phase Ⅳ trials and lifetime study,and evaluation system in our country.更多还原