You need to get customer "s approval for any deviation."
任何偏差都要经过客户的批准。
Methods: The historical background formed American Orphan Drug system, regulation of Orphan Drug system, preferential measure, and FDA s approval procedure are stated.
方法:根据个人掌握的资料,说明美国罕见病药物制度形成的背景、有关法规、优惠措施及FDA审批程序。
In his first six months in the White House, President Barack Obama has seen his approval ratings slip about 10 percentage points as he takes on a battered U. S. economy.
自从奥巴马入主白宫,接手了糟糕的美国经济,时间已经过去了六个月,而他的支持率下降了约10%。
Otherwise, if the customer cancels after auditor1's approval and before auditor2's approval, the system needs to send notices to both auditor1 and auditor2 as the compensation.
否则,如果用户在auditor 1批准之后auditor 2批准之前取消,系统需要发送通知给auditor1和auditor 2作为补偿。
The new world record still awaits official approval from Guinness, but if it turns out to be legitimate, the title of the world's fastest texter will move from the U. S. to England.
这个新的世界纪录依然需要等待吉尼斯官方确认,一旦这个纪录通过,那么世界最快短信输入者的桂冠将会从美国移向英格兰。
We will have to wait and see if we can get approval and consummate that partnership inside the U. S. first.
首先我们必须等待看看我们是否能得到批准和在美国的合作是否完满。
The approval, including the date and signature of the individual (s) approving the requirements, shall be documented.
该批准(其中包括批准需求的人员的签字和日期)应当予以记录。
Should a U. S. resident become a target of such an investigation, court approval still will be required.
如果美国居民成为此类调查的对象,则仍然要徵得法庭批准。
When the client tries to answer the therapist's questions, s/he sees that there is no reason why s/he absolutely must have approval, fair treatment, or anything else that s/he wants.
当来访者尝试回答治疗师的问题时,他们就会发现,其实他们必须得到称赞、公平待遇、想要的一切的想法是无稽之谈。
Trials of the S-ICD began in Europe earlier this year, and Cameron Health hopes to win regulatory approval by the summer.
今年年初欧洲也开始进行s -ICD的研发实验。CameronHealth公司希望夏天前可以获取医药管理部门的许可证。
While multinational drug makers might study experimental medicines in Asian subjects, the companies would use the clinical-trial results to gain regulatory approval in the U. S. and Europe.
虽然跨国制药商可能还在研究针对亚洲实验对象的实验药品,但它们会将临床试验结果拿到欧美市场获取监管机构的批准。
The approval, including the date and signature of the individual (s) approving the output, shall be documented.
该批准(其中包括批准输出的人员的签字和日期)应当予以记录。
Upon approval of the above report, the vessel(s) may enter the port.
经卫生检疫机关对上述报告答复同意后,即可进港。
The assessment comes as a U. S. Food and Drug Administration advisory panel mulls whether to recommend approval of the intravenous drug for atrial fibrillation (AF).
这一评估来源于一个美国食品与药品监督管理局的顾问团提出,对于治疗心房颤动的注射药物是否批准需要进行慎重考虑。
It must pass muster in much more rigorous testing before the company seeks U. S. approval.
在获取美国的批准之前它还必须进行更大范围的试验。
The closing of the acquisition is subject to customary closing conditions, including approval of the acquisition agreement by holders of a majority of CHM "s outstanding stock."
结束本次收购符合惯例成交条件,包括批准该收购协议,由持有人大多数资料交换所机制的未兑现的股票。
Not long ago, the FDA 's Center for Veterinary Medicine announced plans to withdraw approval of the use of fluoroquinolones in poultry feed.
不久前,FDA兽医学中心宣称计划收回在家禽饲料中掺入氟喹诺酮的批文。
More important, the approval of Cape wind could pave the way for other offshore wind farms across the country, opening up a new frontier for renewable energy in the U. s.
更为重要的是,海角风能的批准将为在美国各地兴建近海风电站铺平道路,这为美国的可再生能源开辟出了新的疆域。
Some analysts have said U. S. approval of Qnexa is unlikely this year.
一些分析人士说,美国批准今年Qnexa是不可能的。
These requirements include establishment registration, medical device listing, quality system, medical device reporting, premarket approval or clearance, labeling and U. s. agent requirements.
这些规定包括工厂的注册,医疗设备清单,质量系统,医疗设备报告,售前批准或者认可,商标及美国代理的要求。
Johnson & Johnson is finishing up a required U. S. trial and hopes to apply for approval for preventing leg clots in the second half of 2008. (Bayer has already filed for European approval. )
强生公司正在美国完成必要试验,并且希望能在2008年的下半年中能够得到批准进行防止病人腿部栓塞的治疗。(拜耳公司已经在申请欧洲的批准了)
The Bohai Offshore Wind Power Generation Demonstration Project, China′s first offshore wind turbine generating set with a designed capacity of 1.5MW, received regulatory approval in 2007.
“渤海海上风力发电示范工程”于2007年初批准正式立项,建设国内第一台海上风力发电机组,容量为1.5MW。
Members must obtain a prior approval from the Club General Manager Office in order to ship their boat(s) in or out of the club gate.
会员的船艇如要出入俱乐部,必须预先得到俱乐部总经理办公室的批文。否则保安有权拒绝其出入要求。
Members must obtain a prior approval from the Club General Manager Office in order to ship their boat(s) in or out of the club gate.
会员的船艇如要出入俱乐部,必须预先得到俱乐部总经理办公室的批文。否则保安有权拒绝其出入要求。
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