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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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**FDA Orphan Drug Approvals** provides information on drugs and biologics that have been designated as orphan products by the FDA. Orphan products are intended for the treatment of rare diseases or conditions that affect fewer than 200,000 people in the United States. The site includes information on the orphan drug designation process, a list of approved orphan drugs, and links to additional resources.