Objective: To introduce American Orphan Drug System.

目的：介绍美国罕见病药物制度。

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Methods: The historical background formed American Orphan Drug system, regulation of Orphan Drug system, preferential measure, and FDA s approval procedure are stated.

方法：根据个人掌握的资料，说明美国罕见病药物制度形成的背景、有关法规、优惠措施及FDA审批程序。

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Moreover, approval was contingent on Orphan setting up a system that carefully controls who gets the drug.

FORBES: Former Street Drug Takes On Narcolepsy

AZT, began as an orphan drug for what was then an obscure disease of the immune system.

ECONOMIST: Rare diseases: Safety in numbers | The