In the complete response letter there are no requests for new pre-clinical or clinical trials.
在该完整回复函中,FDA并未要求补充新的临床前或临床研究资料。
The complete response letter does not contain requests related to the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility.
该完整回复函并不包括2009年12月FDA对俄亥俄州生产车间的批准前现场核查有关的要求。
But the U.S. Food and Drug Administration's complete response letter did not request additional clinical trials for the drug, Saphris, and included proposed product labeling for the medicine.
但是,美国食品与药品管理局(FDA)完整的意向函并未要求更多药物的临床试验。Saphris被提议为此药物的药品标签。
Putting off mowing the lawn, or not writing a letter, may not seem like a big deal, but every time you don't carry out tasks you think you should complete, you ignite a mild fight or flight response.
该修剪的草坪一直没剪,或者是一封信总是没有写,看起来都不是什么大事,但是每一次你没有做完你应当完成的工作,你就燃起了一场微弱的斗争或是内心的逃避。
Putting off mowing the lawn, or not writing a letter, may not seem like a big deal, but every time you don't carry out tasks you think you should complete, you ignite a mild fight or flight response.
该修剪的草坪一直没剪,或者是一封信总是没有写,看起来都不是什么大事,但是每一次你没有做完你应当完成的工作,你就燃起了一场微弱的斗争或是内心的逃避。
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