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Biotechnology Innovation Organization· @IAmBiotech · X·· 2 小时前精选AI 评分62
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BIO 对 FDA 启动罕见病框架计划(Rare Disease Framework Initiative)表示赞赏,该计划旨在为罕见病药物开发建立适配的框架。BIO 指出,罕见病患者往往无法被传统药物开发范式所覆盖。

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FDA 推出罕见病药物开发框架计划,行业组织对此表态,读者可了解该监管方向的基本内容。

正文

Patients living with rare disease often cannot be served by traditional drug development paradigms. Today, BIO applauds the FDA for the launch of the Rare Disease Framework Initiative to develop a fit-for-purpose framework for rare disease drug development.

来源:Biotechnology Innovation Organization · x.com