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商业 · 2005/1/261 分钟阅读
Draft Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations; Availability
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摘要
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Nonclinical Safety Evaluation of Drug Combinations." The guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), copackaged products, and adjunctive therapies.
来源原始语言: Federal Register — Food and Drug Administration打开原始公告 →