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Why Trump Could Lose His Trade War With China. With @thomaslfriedman.bsky.social.
open.spotify.com/episode/1twk...
youtu.be/UqBa0hBAQBA?...
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实际上,一款仿制药在通过一致性评价后,可对原材料供应商、生产工艺、生产厂址等多项生产环节进行变更,而无需重新进行一致性评价,多数情况只需在省级药监部门进行备案。
我分析了国家药监局公布的2019年至今的16万余条药物补充备案,发现通过一致性评价的仿制药、进入集采的药品中,广泛存在过评后生产环节的变更。
并且,进入集采的药品,相对于同成分但未进入集采的药品,进行了更多此类变更。
这些变更并非一定会影响药效、安全性,但仍需解决如何对此进行有效监管的问题。
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A classmate posted this in 2015, when we were taking Soc 101 with Michael Burawoy.
No. 9: "Theory is hard. Thank god we have Burawoy."
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Zoom ID: 852 364 4345
Passcode: sociology
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mp.weixin.qq.com/s?__biz=MzI5...
by Yisu Zhou