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国家食药总局督促部分企业进行苄达赖氨酸临床试验
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国家食药总局督促部分企业进行苄达赖氨酸临床试验
2017年12月28日,国家食品与药品管理总局(总局)发函要求安徽省双科药业有限公司、湖北远大天天明制药有限公司、河北医科大学制药厂、杭州民生药业有限公司、宁夏康亚药业股份有限公司、长春普华制药股份有限公司、珠海联邦制药股份有限公司中山分公司尽快启动苄达赖氨酸产品的临床有效性实验,以回应医务界部分医生对苄达赖氨酸滴眼液疗效提出的质疑。总局要求苄达赖氨酸生产企业所在行政区域的相关食药局按照《中华人民共和国药品管理法》及仿制药质量和疗效一致性评价的有关规定,督促本行政区域内苄达赖氨酸滴眼液生产企业尽...
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