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。
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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