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。
FDA can ask for the proof of safety and effectiveness of a product if its distributors challenge FDA's authority.
目的:评估度洛西汀治疗慢性下腰痛的安全性和有效性。
Objective. To assess the efficacy and safety of duloxetine in the treatment of chronic low back pain (CLBP).
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, a company must demonstrate the safety and probable benefit of the device.
目的探讨高强度聚焦超声治疗胰腺癌的安全性和有效性。
Objective To evaluate the efficacy and clinical feasibility of high-intensity focused ultrasound in the treatment of pancreatic cancer.
目的:探讨LASIK治疗混合性散光的安全性和有效性。
Objective: to investigate the effectiveness and safety of laser in-situ keratomileusis (LASIK) for mixed astigmatism.
目的:评估补充叶酸对于预防结直肠腺瘤的安全性和有效性。
Objective To assess the safety and efficacy of folic acid supplementation for preventing colorectal adenomas.
极端低碳水化合物饮食的长期安全性和有效性完全无法证实。
It's completely unsubstantiated that a very-low-carbohydrate diet is safe and effective in the long term.
对于小于一岁的患者,耐信的安全性和有效性尚未得到证实。
The safety and efficacy of Nexium has not been established in children less than one year of age.
该药在肝或肺移植患者中的安全性和有效性尚未经FDA确认。
The safety and efficacy of this drug in liver or lung transplant patients have not been established by the FDA.
目的观察外科手术患者术中输注冰冻红细胞的安全性和有效性。
Objective To observe the efficaly and safely of frozen red blood cells in the operative patients.
《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。
Penicillin Amendment requires FDA testing and certification of safety and effectiveness of all penicillin products.
本研究的目的即是评估震波治疗这些骨不愈合的安全性和有效性。
The purpose of this study was to evaluate the safety and efficacy of shock wave therapy as a treatment of these nonunions.
目的观察钾在临床上预防PT CA术后再狭窄的安全性和有效性。
Objectives To investigate safety and effectivity of potassium in prevention of restenosis after PTCA.
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。
Objective:To explore the safety and effectiveness of early enteral nutritional support in acute severe pancreatitis patients.
这种方法在安全性和有效性方面都存在很多问题,如容易检测和攻击。
These schemes have many disadvantages in security and efficiency, ex. they can easily be detected and attacked.
目的:评价吲哚菁绿(ICG)晶状体前囊染色方法的安全性和有效性。
Objective: To evaluate the efficacy and safety of indocyanine green (ICG) in staining rabbit's anterior lens capsule.
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。
The purpose of clinical trials of medical devices is to evaluate the intended safety and effectiveness of the testing products.
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。
For those who try other options to reduce cholesterol, it's important to work closely with a doctor to monitor safety and effectiveness.
但是,在活动受限的老年患者中,应用睾酮的安全性和有效性至今仍然未知。
The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied.
世卫组织及其合作伙伴正在评估最初大规模免疫接种运动的影响,包括其安全性和有效性。
WHO and its partners are currently assessing the impact of the initial mass immunization campaigns, including their safety and efficacy.
令人吃惊的是有相当多的治疗方法都存在安全性和有效性方面的问题,包括一些手术手段。
There are questions about the safety and efficacy of a surprising number of therapies, including some types of surgery.
《国际循环》:关于口服抗凝药治疗,我们如何保持安全性和有效性之间的平衡?
International Circulation: In oral anticoagulant therapy, how can we make the balance between safety and efficacy?
还需要能够跟着错误和程序输出,并需要能够确保脚本的执行环境的安全性和有效性。
You also need to be able to trap errors and output from programs and ensure the security and validity of the environment in which the script executes.
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 safety and effectiveness of Boostrix was based on a study of about 1,300 people ages 65 and older.
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。
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;
目的探讨白内障超声乳化折叠式人工晶状体植入术治疗闭角型青光眼的安全性和有效性。
Objective to observe the effectiveness and safety of combined phacoemulsification with intraocular lens (IOL) implantation and trabeculectomy in patients with cataract and glaucoma.
目的:评价手助腹腔镜根治性肾输尿管全切术治疗上尿路移行细胞癌的安全性和有效性。
Objective:To investigate the clinical results of hand-assisted laparoscopic radical nephroureterectomy and evaluate its effectiveness and safety for upper tract transitional cell carcinoma.
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.
就像让食品和药物管理局要求药品公司自行测试新药物的安全性和有效性——一位批评者指出。
Or having the Food and drug Administration let drug companies test the safety and efficacy of new drugs, one commenter points out.
就像让食品和药物管理局要求药品公司自行测试新药物的安全性和有效性——一位批评者指出。
Or having the Food and drug Administration let drug companies test the safety and efficacy of new drugs, one commenter points out.
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