To receive approval, a company must demonstrate the safety and probable benefit of the device.
要想获得批准,厂商必训证明该设备的安全性和有效性。
To receive approval of an HDE application, a company must demonstrate the product's safety and probable benefit.
为了获得HDE申请的批准,它们必须保证其产品的安全性及可能盈利。
Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.
如果制药公司希望标记OT C但没有达到专著要求的,均可以提交新药上市的申请和获得注册新药的许可。
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