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近10年来美国药品管理部门对一些销路不广,但对某些特殊病症和罕见疾病具有独特疗效的药物比较重视其开发研究。此类药物的通称系采用俚语命名为Orphan Drug;本文译为奥芬药物。从1983年起美国F D A即根据“联邦药物、食品、化妆品法”(Fede-ral Food, Drug, and Cosmetic Act)第526款制订了奥芬药物法(Orphan Drug Act)。这也是一种政策倾斜, 以便鼓励和保护对此类药物的开发和研究。这里所谓“罕见病”是指在美国国内发病人数少
In the past 10 years, the drug administration of the United States has paid more attention to the development and research of some drugs that have not been widely sold but have unique curative effects on some special and rare diseases. The generic term for such drugs is the slang name Orphan Drug; this article translated as Offengen. Since 1983, the U.S. FDA has established the Orphan Drug Act under section 526 of the “Fede-ral Food, Drug, and Cosmetic Act.” It is also a policy tilt to encourage and protect the development and research of such drugs. The so-called “rare disease ” refers to the small number of patients in the United States