医疗器械的上市前批准 PREMARKET APPROVAL OF MEDICAL DEVICES
这意味着他们不是作为已批准药物经过相同的上市前审核。
This means that they have not undergone the same premarket review as approved drugs.
这意味着它们没有作为已批准药物经过相同的上市前审核。
This means that they have not undergone the same premarket review as approved drugs.
这是因为，如果一家制药公司决定继续这条路，在获得批准上市前他们将必须进行为期十年的心血管安全性研究。
This is because if a pharmaceutical company decided to go down that road they will have to perform a cardiovascular safety study for 10 years before they can get the drug approved.
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