批准了行动计划,只有少量行动(107项行动中的9项)尚未获得批准。
Plan of action approved except for a small number of actions (10 out of 107 actions) which remained open.
任何司向美国进口和销售这种未获得批准的用于脂肪溶解术的药物的行为都违反了美国食品药品化妆品法案。
Importing and distributing unapproved drug products is a violation of the Federal Food, drug, and Cosmetic Act.
在一些这样的事件中,FDA授权药品制造商给予患者尚在进行安全性和有效性评价而未获得批准的药物。
In some of these cases, FDA authorizes the manufacturer to provide patients with access to a drug that is still being tested for safety and effectiveness but is not yet approved.
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