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。
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。
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