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美国FDA《联邦食品、药品和化妆品法》细目

(2015-06-19 10:09:22)
标签:

研发

分类: 双语简称,缩写

(a)(1)“州”(State)

    (2)“准州”(Territory)

(b)“州际贸易”(interstate commerce)

(c)“部”(Department)

(d)“部长”(Secretary)

(e)“人”(person)

(f)“食物”(food)

(g)(1)“药物”(drug)

    (2)“假冒药物”(counterfeit drugs)

(h)“器械”(device)

(i)“化妆品”(cosmetic)

(j)“法定典集(official compendium)

(k)“标签”(label)

(l)“直接容器”(immediate container)

(m)“标识”(labeling)

(n)与标识或广告有关的错误标识(misbranded)

(o)说明为防腐剂(antiseptic)的标识(p)“新药”(new drug)

(q)(1)“化学杀虫剂”(pesticide chemical)

    (2)“化学杀虫剂残留物” (pesticide chemical residue)

    (3)环境保护总署署长(Administrator)依法禁止的情况(r)“未加工的农产品”(raw agricultural commodity)

(s)“食物添加剂”(food additive)

(t)(1)“颜色添加剂”(color additive)

    (2)“颜色”(color)

(u)“安全”(safe)

(v)“新兽药”(new animal drug)

(w)“动物饲料”(animal feed)

(x)“非正式听证会” (informal hearing)

(y)“糖精”(saccharin)

(z)“婴儿配方”(infant formula)

(aa)“简化药物申请”(abbreviated drug application)

(bb)“故意地”(knowingly)或“已知的”(knew)

(cc)“高级管理代理”(high managerial agent)

(dd)“药品”(drug product)

(ee)“专员”(Commissioner)

(ff)“饮食补充剂”(dietary supplement)

(gg)“已加工的食物”(processed food)

(hh)“署长”(Administrator)

(ii)“复合的正电子发射断层摄影术药物”(compounded positron emission tomography drug)

(jj)“抗生素”(antibiotic drug)

食物中有毒成分的容许(TOLERANCES FOR POISONOUS INGREDIENTS IN FOOD

 

(C)核准(AUTHORIZATION)

(D)处理(TREATMENT)

(E)审查(REVIEW)

(F)紧急申请程序(URGENT PETITION PROCEDURE)

(G)性能标准(PERFORMANCE STANDARDS)

 标准的规定(Provision of Standards)

 标准的建立(Establishment of a Standard)

 标准的认可(Recognition of a Standard )

(H)对申请批准的撤销和暂时中止(Withdrawal and Temporary Suspension of Approval of Application

(I)审查的标准(Standard for Review)

3)“制造商”(manufacturer)(4)“新用途”(new use)

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