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FDA孤儿药批准

FDA孤儿药批准

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孤儿药认定(ODD)是FDA对符合条件的用于预防、治疗及诊断罕见病的药物(包括生物制品)授予的一种资格认定。

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Highlights

FDA Orphan Drug Approvals is a searchable database of the therapeutic biologics, drugs, and medical devices that have received orphan designation since January 1, 1983. The database contains detailed information on each product, including its approval date, indication, sponsor, and marketing status.