FDA can ask for the proof of safety and effectiveness of a product if its distributors challenge FDA's authority.
如果经销商对FDA的权威提出质疑，FDA可以要求他们提供产品安全性和有效性的证明。
That means their safety and effectiveness is not proved.
这就意味着它们的安全和疗效并未得到证明。
Which are the criteria to evaluate the safety and effectiveness of OADs treatment?
用来评价口服降糖药治疗的安全性和有效性的指标有哪些？
Safety and effectiveness are close sisters, accidents and losses are twin brothers.
安全与效益是亲密姐妹，事故与损失是孪生兄弟。
However there are still many unknowns surrounding the safety and effectiveness of that strategy.
然而，关于此道的安全性与有效性仍有许多未知数。
However, there are still many unknowns surrounding the safety and effectiveness of that strategy.
然而，关于此道的安全性与有效性仍有许多未知数。
The safety and effectiveness of Boostrix was based on a study of about 1,300 people ages 65 and older.
Boostrix的安全性和有效性是根据一项年龄65和以上约1,300人研究。
The second category means those medical instruments whose safety and effectiveness shall be controlled.
第二类是指，对其安全性、有效性应当加以控制的医疗器械。
The safety and effectiveness of the active ingredient in this product have not been demonstrated to the FDA.
FDA法规事务代理副专员迈克尔 夏贝尔说：“该产品活性成分的安全性、有效性未向FDA提出。
Test safety and effectiveness: develop clear metrics, use them to validate and improve safety practices.
测试安全有效性：制定明确指标，使用它们验证和改进安全实践。
On Friday the FDA will ask a panel of experts to weigh in on the safety and effectiveness of Boehringer's drug.
周五，食品药监局将会邀请一个专家小组来衡量勃林格公司新药的安全性和效用。
To evaluate the safety and effectiveness of clinical application of blue-light filtering intraocular lens.
目的探讨滤蓝光型人工晶状体临床应用的有效性与安全性。
Penicillin Amendment requires FDA testing and certification of safety and effectiveness of all penicillin products.
《青霉素修正案》要求FDA检验并保证所有青霉素制品的安全性和有效性。
The safety and effectiveness of clofarabine have not been established in geriatric patients 65 years and older.
年龄大于等于65岁患者的药物的安全和有效性还未建立。
Class I Medical Devices are those for which safety and effectiveness can be ensured through a routine administration.
第一类医疗器械是指，通过常规管理足以保证其安全性、有效性的医疗器械。
AIM: To evaluate the safety and effectiveness of Ahmed glaucoma valve device in the treatment of neovascular glaucoma.
目的：探讨青光眼减压阀引流术治疗新生血管性青光眼的有效性和安全性。
But the research on this treatment is still at an early stage, and many questions remain about its safety and effectiveness.
不过，针对这种疗法的研究还处于初级阶段，有关其安全性及疗效还存在许多问题。
Objective:To explore the safety and effectiveness of early enteral nutritional support in acute severe pancreatitis patients.
目的：探讨急性重症胰腺炎病人早期肠内营养支持的安全性和有效性。
The purpose of clinical trials of medical devices is to evaluate the intended safety and effectiveness of the testing products.
医疗器械临床试验的目的是评价受试产品是否具有预期的安全性和有效性。
As a condition of FDA approval, the company will evaluate the safety and effectiveness of the device during the next eight years.
作为FDA批准的条件，该公司将会在未来的八年中评估该装置的安全性和功效性。
Objective: To observe the safety and effectiveness of several drugs in chest surgical analgesic and collect datas for the clinic.
目的：观察不同药物用于胸科术后镇痛的安全性有效性，为临床术后镇痛应用积累资料。
The first category means those medical instruments whose safety and effectiveness may be adequately ensured by ordinary management.
第一类是指，通过常规管理足以保证其安全性、有效性的医疗器械。
Natural anti-inflammatory substances target a much broader range of inflammatory compounds, leading to greater safety and effectiveness.
而自然界里的抗组织胺物质可以抑制多种炎症混合物的产生，会给健康带来更大的安全作用。
For those who try other options to reduce cholesterol, it's important to work closely with a doctor to monitor safety and effectiveness.
对那些用其他方法降低胆固醇的人，有必要让医生来监护其安全性和有效性。
These manufacturers shall establish and implement quality systems to assure the safety and effectiveness of the devices that are distributed.
这些制造商也应建立和实施质量体系，确保其销售的器械的安全和有效。
Almost half (16) were approved under “priority review,” in which the FDA has a six month goal to complete its review for safety and effectiveness;
几乎半数(16种)是“优先审评,”下批准其中FDA有6个月目标完成安全性和有效性审评。
Before dissolving microneedles can be made widely available, however, clinical studies will have to be done to assure safety and effectiveness.
不过，在可降解微针帖片大量投入使用之前，应该有临床试验研究来确保其安全性与有效性。
AIM: to observe the clinical feasibility, safety and effectiveness of autologous marrow stem cells transplantation in treating acute myocardial infarction.
目的：观察自体骨髓干细胞移植治疗急性心肌梗死的临床可行性、安全性和有效性。
The gel was marketed as a product that could kill 99.99 percent of viruses, bacteria, and fungi. However, its safety and effectiveness have not been established.
该凝胶宣称能杀灭99.99%的病毒、细菌、真菌，但却未能提供安全性和有效性数据。
The gel was marketed as a product that could kill 99.99 percent of viruses, bacteria, and fungi. However, its safety and effectiveness have not been established.
该凝胶宣称能杀灭99.99%的病毒、细菌、真菌，但却未能提供安全性和有效性数据。
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