美國食品藥品管理局（FDA）于2020年9月發(fā)布了供企業(yè)用"處方藥和生物制品說明書中的老年用藥信息"指導原則。該指導原則主要介紹對說明書中老年用藥信息位置和內(nèi)容的要求并給出描述的示例。內(nèi)容極其詳細、具體，便于操作。而我國尚無類似指導原則，詳細介紹該指導原則，期望對我國相關(guān)指導原則的起草及其上位法規(guī)的修訂有幫助，對藥品說明書老年用藥信息的撰寫也有益。

FDA issued Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry in September 2020. This guidance mainly introduces the requirements for the placement and content of geriatric information in labeling, and gives examples of description. The content is extremely detailed and specific, which is easy to operate. However, there is no similar guidance in China. This paper introduces the guidance in detail, hoping to be helpful to the drafting of relevant guidances and the revision of upper regulations in China, as well as the writing of geriatric information in drug labelings.

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