美国食品药品监督管理局没有获得关于这些声称的任何临床证据。
The FDA is not aware of clinical evidence to support any of these claims.
美国食品药品监督管理局称这些新药的评价将基于患者不确定使用的假设上。
The FDA has said it will evaluate the new drugs under the assumption that patients would use them indefinitely.
我们相信我们的营销实践完全是基于美国食品药品监督管理局批准的处方信息。
We believe that our sales and marketing practices are solely based on our prescription information as approved by the U. S. Food and Drug Administration.
本文介绍了美国食品药品监督管理局关于抗菌药物临床试验非劣效设计的考虑。
This article is to introduce FDA's(Food and Drug Administration, FDA)considerations of non-inferiority design used in anti-bacterial drug clinical trial.
美国食品药品监督管理局目前并没有设定规范或决定设定规范去管理食品中的盐含量。
The FDA is not currently working on regulations nor has it made a decision to regulate sodium content in foods at this time.
在4月9日的警告信中美国食品药品监督管理局称在调查试验中几名临床观察中时发现其严重违规的。
In the warning letter, dated April 9, the FDA said "significant violations" were found during inspections of several clinical investigators involved in the studies.
新英格兰杂志在社论上呼吁召回该药物。美国食品药品监督管理局也已经警告心脏病患者不要服用此药。
The New England Journal, in an editorial, called for the drug to be withdrawn, and the FDA has already warned cardiac patients against taking the drug.
本周二美国食品药品监督管理局在其网站张贴了关于辉瑞公司实施的一项不知名药物的临床试验的警告。
The FDA posted a warning letter on its Web site Tuesday concerning clinical trials of an unnamed drug that the agency said was sponsored by Pfizer.
美国食品药品监督管理局的警告的措辞巧妙地暗示了应仔细评估这些类药物的功效和不良反应危害的要求。
The FDA warning is nicely phrasedto point out the need for careful clinical evaluation of therisks and benefits of these drugs.
美国食品药品监督管理局日前发出警告,指出处于心脏搭桥手术围手术期的患者不可使用双氯芬酸缓解疼痛。
The FDA recently issued a warning stating that diclofenac should not be used by people for pain in the time period surrounding heart bypass surgery.
据美国食品药品监督管理局报道:在三分之二的病例中,食物传播的疾病可以导致严重的长期的健康问题。
But in 2 to 3 percent of cases, food-borne disease can cause serious long-term health problems, according to the U. S. food and Drug Administration.
美国食品药品监督管理局本月将会召开为期三天的会议来讨论是否允许这种基因改造的鱼类供美国消费者食用。
The US Food and Drug Administration will hold a three-day meeting this month to discuss whether to approve the altered fish for American consumers to eat
美国食品药品监督管理局已经责令山达基教会宣布这种仪器没有治疗作用,并且在诊断和治疗疾病方面也是无效的。
The Food and Drug Administration has compelled the church to declare that the instrument has no curative powers and is ineffective in diagnosing or treating disease.
如果食品工业、餐馆和公民每天减少盐的摄入,美国食品药品监督管理局说,全国心血管疾病的负担会得到缓解。
If the food industry, restaurants and citizens cut their daily salt intake, the FDA says, the national burden of cardiovascular disease would be eased.
去年六月,美国食品药品监督管理局组织外界医学专家就Geodon和其他两个药物用于青少年治疗进行了讨论。
Last June, an FDA panel of outside medical experts met to consider Geodon along with two other drugs for pediatric use.
美国食品药品监督管理局执行懂事在记者发布会中说“这个问题很严重,但现在还不能说FDA将采取进一步措施。”
"The findings are serious, but we cannot say yet whether further action by the FDA is warranted, " Deborah Autor, the FDA's director of compliance, said in a conference call with reporters.
美国食品药品监督管理局已经警告辉瑞公司(Pfizer),称其安定药Geodon的青少年临床试验严重违规。
The Food and Drug Administration has warned Pfizer Inc. of "significant violations" involving pediatric trials of its antipsychotic drug Geodon.
美国食品药品监督管理局(FDA)于今日发布了上述安全通告,并提醒医护人员,新旧两种肝素制剂将会同时存在一段时间。
The Food and Drug Administration (FDA) issued the safety communication today and is warning healthcare professionals that both the old and new formulations of heparin will be available for some time.
周四Vivus公司的减肥药物Qnexa将接受外部评审专家评价,这是该药物获得美国食品药品监督管理局批准的重要一步。
Vivus Inc. Thursday will take a key step in gaining Food and Drug Administration approval of its experimental weight-loss drug Qnexa when it faces an agency panel of outside experts.
今年七月,美国食品药品监督管理局的专家小组就已经因为包括心悸在内的安全问题建议撤销Vivus公司生产的减肥药Qnexa。
In July, the FDA's expert panel recommended against another proposed diet drug, Qnexa, made by Vivus inc., because of safety issues that included heart palpitations.
到目前为止,4种对抗h1n 1病毒的疫苗已经获得美国批准,其生产过程与美国食品药品监督管理局监管下的季节性流感疫苗生产过程相同。
So far, four vaccines against the H1N1 virus have been approved in the United States under the same process used by the Food and Drug Administration (FDA) for seasonal flu vaccines.
虽然FDA(美国食品药品监督管理局)还没有批准抗氧化剂用于治疗慢性疼痛,但沿着这条路走下去我们会发现含抗氧化剂的药物是有效的。
The FDA hasn't approved antioxidants for the treatment of chronic pain. But down the road we may see some drugs that contain antioxidants.
三月份,罗氏和生物基因艾迪克就研究中的新发现向美国食品药品监督管理局(Foodand Drug Administration)提出新应用的申请。
In March, Roche and Biogen Idec filed an application with the U.S. Food and Drug Administration seeking expanded approval of Rituxan as reflected in the study's findings.
WHO将提供有用的建议,并为那些过于贫穷以至于连医疗管理机构(类似于美国的FDA,食品药品监督管理局)都没有的国家,建立规范的卫生标准。
The agency provides useful advice and sets technical standards for countries too poor to have proper medical regulators like America's Food and Drug Administration.
举一个例子,在美国,食品药品监督管理局(FDA)允许销售医疗设备,只要能够保证这些设备带给患者的益处大过其风险。
For example, in the United States, the food and Drug Administration (FDA) to allow the sale of medical equipment, as long as these devices can ensure the benefits outweigh the risk to patients.
今天,美国食品和药物管理局(FDA)发出的无线电频率,无线技术在医疗器械工业和食品药品监督管理局人员指导。
Today the Food and Drug Administration (FDA) issued the Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff.
今天,美国食品和药物管理局(FDA)发出的无线电频率,无线技术在医疗器械工业和食品药品监督管理局人员指导。
Today the Food and Drug Administration (FDA) issued the Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff.
应用推荐