1983年1月4日美国国会通过的美国《罕见病药物法》(Orphan Drug Act)是根据《联邦食品药品和化妆品法》(Frederal Food…www.healthoo.com|基于30个网页 2. 罕见病药品法 通过《罕见病药品法》(ORPHAN DRUG ACT),使FDA能鼓励治疗罕见病(rare diseases)需要的药品的研究和上市。 198…www.fdc-intl.com|基于23个...
关于美国《罕见病药物法案》(OrphanDrugAct),表述正确的是: A. 1983年通过 B. 罕见性疾病是指患者人数不超过200,000人的疾病 C. 该法案规定
The Orphan Drug Act is not about children without parents. 这个孤儿药法案与失去父母的孩子无关。 The term "orphan drugs" refers to medical products that would not be adopted by major pharmaceutical companies 孤儿药品这个术语是指非主要制药公司生产的药品。 because they serve only a very small por...
(redirected fromOrphan Drug Act) Also found in:Medical,Acronyms,Encyclopedia. or′phan drug′ n. a drug that remains undeveloped or is neglected because of limited potential for commercial gain. [1975–80] Random House Kernerman Webster's College Dictionary, © 2010 K Dictionaries Ltd. Copyright...
Orphan Drug ActFood and Drug AdministrationTherapeutic Innovation & Regulatory Science - This paper provides an overview of orphan drug legislation in the United States. Since passage of the Orphan Drug Act in 1983, 182 designated...Haffner, Marlene E....
a他上周末去了沙滩。 His last weekend has gone to the sand beach.[translate] athe Orphan Drug Act is an example of a pure ex post IP regime that directly incentivizes commercialization. 孤儿药物行动是直接地incentivizes商品化一个纯净的事后IP政权的例子。[translate]...
a2.不能因為貨少,而不提供FA 2. cannot be few because of the goods, but does not provide FA[translate] awe stress that the real significance of the 我们注重真正的意义的[translate] aReaction to fire[translate] aThe Orphan Drug Act 孤儿药物行动[translate]...
孤儿药(Ophan Drug)是指用于诊断、治疗和预防罕见病的药品,而罕见病是一类发病率极低的疾病的总称,又被称为“孤儿病”。 根据世界卫生组织(WHO)的定义,患病人数占总人口0.65‰～1‰的疾病即可被定义为罕见病。不过,世界各国根据自己国家的具体情况,对罕见病的认定标准存在一定差异。 根据FDA的定义,“孤儿药”是...
The Orphan Drug Act.The Orphan Drug Act.Compares the pre- and post-1983 Orphan Drug Act industry and government data to examine changes associated with the U.S. law. Lack of patent protection; Problems generated by market exclusivity provision; Development of aerosolized pentamidine products.Asbury...
罕见病药物又称为“孤儿药”( orphan drug) ,包括药物、疫苗及诊断试剂,用于预防、诊断或治疗罕见病。美国于1983年颁布《孤儿药法案》( Orphan Drug Act,ODA) [3],逐步建立鼓励罕见病药物研发的长效机制。ODA 实施37 年以来,美国罕见病药物研发和审批取得突破性进展。本文主要通过对美国罕见病药物临床试验、资格认...