纯食品与药品法案Pure Food and Drugs Act
联邦食品、药品与化妆品法案Federal Food,Drugs and Cosmetic Act
新药申请New Drug Application, NDA
卡法尔-哈里斯法案Kefauver-Harris Amendment
药品价格竞争与专利期补偿法案Drug Price Competition and Patent Term Restoration Act; Hatch-Waxman
简化新药申请Abbreviated New Drug Application, ANDA
医疗保险处方药与现代化法案Medicare Prescription Drug,Improvement, and Modernization Act, MMA
更易获得可支付药品法案Greater Access to Affordable Pharmaceutical Act, GAAP
经治疗等同性评价批准的药物
Approved drug products through thereapeutic equivalence evaluation
专利悬崖patent cliff是指一个专利保护到期后，企业依靠专利保护获得的销售额和利润就会一落千丈
单方法院禁令ex-parte injunction
”告示系统“notification system
宣告式判决declaratory judgment
参比制剂Reference Listed Drug, RLD
标准制剂Reference Standard,RS
联邦贸易委员会Federal Trade Commission,FTC
上市许可持有人Marketing Authorization Holder,MAH
公共健康服务法（the Public Health Service Act
联邦巡回上诉法院
the United States Court of Appeals for the Federal Circuit,CAFC
新化学实体New Chemical Entity, NCE
仿制药使用者付费法再授权
Generic Drug User Fee Act Reauthorization, GDUFA II
生物类似药使用者付费法再授权
Biosimilar User Fee Act Reauthorization, BsUFA II
美国发明法案America Invents Act, AIA
专利审判及上诉委员会Patent Trial and Appeal Board,PTAB
多方复审 Inter Parte Review, IPR
