美国食品药品监督管理局要求礼来进行上市后试验,评估胃排空延迟风险及对哺乳期母亲的潜在影响

美股速递
Apr 14

美国食品药品监督管理局(FDA)已正式要求制药巨头礼来公司开展上市后临床试验。这些试验旨在深入评估其相关药物可能引发的胃排空延迟风险,以及药物对哺乳期母亲及其婴儿的潜在影响。此举是FDA对药物上市后安全监测的常规要求的一部分,以确保药物在更广泛人群使用中的长期安全性数据得到持续收集与分析。

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