包含pdf格式的参考指南文件。
新指南适用于所有未被批准的药物,但代理商以另一个指南文件来评估已批准药物的心血管安全性。
The new guidance applies to all unapproved drugs, but the agency is working on another guidance document to evaluate the cardiovascular safety of drugs already approved.
本指南文件旨在协助卫生官员在局势复杂、模棱两可、甚至时常布满狡猾陷阱的专利信息中更轻易的寻找到所需信息。
The guide aims to help health officials navigate more easily through a landscape of patent information that is complex, sometimes murky, and often riddled with tricky pitfalls.
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