AARP [=American Association of Retired Persons]美国退休者协会
abscesses 脓肿
abstinence 戒酒
acetylcholine 乙酰胆碱
acrylamide 丙烯酰胺
Acting Deputy Commissioner for Policy 政策代理副专员
actinic keratosis 光化性角化病
activity 活度
acylcarnitines 酰基肉毒碱
adhesive pads 粘性衬垫
Administration on Aging 老龄局
Administrative Procedure Act 《行政程序法》
adult cattle 成年牛
adulterated 劣质的
advance notice of proposed rulemaking 建议的规章制定的事先通知
advanced metastatic prostate cancer 晚期转移性前列腺癌
Advisory Committee on Immunization Practices 免疫规范顾问委员会
Advisory Committee Oversight and Management Staff 顾问委员会监督和管理机构
advisory panel 顾问组
aerosol products 喷雾剂产品
African Americans 非洲裔美国人
agent 代理商
Airway Bill number 空运单号
albuterol metered-dose inhalers 沙丁胺醇定量吸入器
alcohol abuse 酒精滥用
alcohol dependent individual 酒精依赖者
alcoholism 酒精中毒
allegations 主张
Allergen Labeling and Consumer Protection Act 《2003年变态反应原标识和消费者保护法》
American Association of Retired Persons 美国退休者协会
American Association of Tissue Banks 美国组织库协会
American Cancer Society 美国癌症学会
American Healthcare Association 美国医疗保健协会
American Nurses Association 美国护理学会
American Nurses Foundation 美国护士基金会
American Society for Nutritional Sciences 美国营养科学学会
American Society for Pharmacology and Experimental Therapeutics 美国药理学与实验治疗学会
American Society on Aging 美国老龄协会
amputation 截肢术
ANA [=American Nurses Association 美国护理学会
anabolic steroid 促合成代谢类固醇
androstenedione 雄烯二酮
ANF [=American Nurses Foundation]美国护士基金会
angiogenesis inhibitor 血管发生抑制剂
angioplasty 血管成形术
Animal Drug User Fee Act 《兽药用户收费法》
animal feed ban 动物饲料禁令
ANPR [=advance notice of proposed rulemaking]建议的规章制定的事先通知
ANPRM [=advance notice of proposed rulemaking]建议的规章制定的事先通知
Anti-Infective Drugs Advisory Committees 抗感染药物顾问委员会
antibiotic bone cement 抗生素骨水泥
antidepressant medications 抗抑郁药
antiperspirants 止汗剂
AoA [=Administration on Aging]老龄局
Applications for Approval to Market a
New Drug; Complete Response Letter; Amendments to Unapproved
Applications 《用于批准的上市新药申请;完全回应函;对未批准申请的修正》
appropriations 拨款
approvable letters 可批准函
Arthritis Advisory Committee 关节炎顾问委员会
artificial spinal disc 人工脊椎盘
ASPET [=American Society for Pharmacology and Experimental Therapeutics]美国药理学与实验治疗学会
Assistant Attorney General 助理首席检察官
Assistant Commissioner for Legislation 立法助理专员
Assistant General Counsel for Regulatory Issues 监管问题总顾问助理
Associate Commissioner for Legislation 立法副专员
Associate FDA Commissioner for External Relations 外关系准局长
Automatic External Defibrillator 自动体外除颤器
baby formula 婴儿配方
bar codes 条形码
behavioral risk factors 行为风险因子
Bill of Lading 提单号
biodefense countermeasures 生物防卫对抗措施
biologics license 生物制品许可证
biopsy 活组织检查
biosecurity program 生物安全项目
black box 黑框
black-box warning 黑框警告
blepharospasm 眼睑痉挛
blinded data 隐蔽数据
blinded review 盲性审查
blood clots 血栓
blood group and type 血型
blood-letting 放血
bloodsucking aquatic animals 吸血水生动物
bone marrow suppression 骨髓抑制
bookend “书档”(广告)
botanicals 植物性药材
Botulinum Toxin Type A A型肉毒杆菌毒素
bovine spongiform encephalopathy 牛海绵状脑病
brand-name data 商品名数据
brand-name drugs 商品名药
breastfeeding 母乳喂养
Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements 《简明摘要:在面向消费者的印刷广告中公开风险信息》
broad-spectrum antibiotic drug 广谱抗生药
broker 经纪人
BSE [=bovine spongiform encephalopathy]牛海绵状脑病
BSE positive animal 疯牛病确诊动物
budget authority 预算授权
bulk drug 原料药
business outreach 商业拓展
CAD [=computer aided detection]计算机辅助检测
calcium x phosphorus ion product 钙磷离子积
calendar year 2004 2004历年
Calories Count 热量计数
Calories Count Report 卡路里计算报告
Canadian Food Inspection Agency 加拿大食品检验局
cardiac arrest 心跳骤停
cardiac arrhythmias 心律失常
cardiopulmonary resuscitation 心肺复苏术
caregiver 护理者
carnitine 肉毒碱
carotid artery 颈动脉
carotid endarterectomy 颈动脉内膜剥离术
case studies 案例研究
casein 酪蛋白
cataract 白内障
category of illicit drug abuse 非法药物滥用类别
cattle-derived material 牛源性材料
CBP [=Customs and Border Protection]美国海关和边境保护局
CDISC [=Clinical Data Interchange Standards Consortium]临床数据交换标准协会
Center for Veterinary Medicine FDA的兽药中心
Centers for Medicare & Medicaid Services 医疗社保与医疗救助服务中心
Centers for Medicare and Medicaid Services 医疗社保与医疗救助服务中心
CEO [=Chief Executive Officer]首席执行官
cervical cancer 子宫颈癌
cervical dystonia 颈部张力障碍
CFH [=Council on Family Health]家庭健康理事会
CFIA [=Canadian Food Inspection Agency]加拿大食品检验局
CGMP [=current good manufacturing practice]现行良好制造规范
CHD [=coronary heart disease]冠心病
chemical entities 化学个体
chemical messenger 化学信使
chest wall 胸壁
chicks 雏鸡
Chief Executive Officer 首席执行官
Chief Operating Officer 首席运营官
Chief Programs Officer 首席项目官员
chloramphenicol 氯霉素
chlorofluorocarbon propellants 氟氯化碳喷射剂
chronic alcoholism 慢性酒精中毒
chronic obstructive pulmonary disease 慢性阻塞性肺病
Citizen Petitions 公民申请书
Civil Division 司法部民事处
civil lawsuit 民事诉讼
Clinical Data Interchange Standards Consortium 临床数据交换标准协会
clusters 疾病群
CMC [=current chemistry, manufacturing and controls]现行化学、生产和控制
CMS [=Centers for Medicare & Medicaid Services]医疗社保与医疗救助服务中心
co-packaged 组合包装
cochlear implants 耳蜗植入物
cognitive disorders 认知障碍
color additives 色素添加剂
color certification 色素认证
colorectal cancer 直肠癌
combined complication 复合并发症
commission 代理酬金
Committee on Energy and Commerce 能源和商务委员会
Commodity Credit Corporation 商品信贷机构
common symptom 常见症状
community helpline 社区热线服务电话
competitive sourcing reviews 竞争源审查
complaint 诉讼
complete response letters 完全回应函
compliance policy guide 稽查政策指南
compliance summary 稽查概要
compounding pharmacies 从事复方的药房
compression device sleeves 压迫器气袖
compromised immune systems 缺乏抵抗力的免疫系统
computed tomography ,CT 算机体层摄影术
computer aided detection 计算机辅助检测
computerized systems 计算机化系统
condemn 没收
consent decree 同意判决书
consistency 一致性
consolidator 承运人
conspirator 同谋
consultation/notification processes 咨询/通知工作
Consumer Advisory 消费者忠告
consumer complaint coordinator 消费者投诉协调人
Consumer Litigation Section 消费者诉讼组
consumer tips 消费者告诫
consumer-friendly 消费者友好
contact lenses 隐形眼镜
contaminants 污染物
contingency response plan 偶然事件反应计划
contraindicate 禁用
controlled substances 管制物质
Controlled Substances Act 《管制物质法》
conventional foods 传统食品
COPD [=chronic obstructive pulmonary disease]慢性阻塞性肺病
core foods 核心食品
corneal swelling 角膜肿胀
coronary artery by-pass surgery 冠状动脉旁路手术
coronary heart disease 冠心病
Cosmetic, Toiletry, and Fragrance Association 化妆品、化妆用具和香料协会
Council on Family Health 家庭健康理事会
Council on Pharmaceutical Quality 药品质量委员会
Cox-2 selective 选择性环氧化酶2抑制剂
CPG [=compliance policy guide]稽查政策指南
CPR [=cardiopulmonary resuscitation]心肺复苏术
crayfish 小龙虾
Critical Path initiative 关键性通道行动
Critical Path Opportunities List 《关键性通道机遇目录》
critical reprocessed SUDs 高风险的再加工一次性使用器械
Cross Center Initiatives Taskforce 交互中心动议工作组
cross contamination 交叉污染
cross-cutting Oncology Program 跨领域的肿瘤项目
crustacean shellfish 甲壳类水生动物
CSA [=Controlled Substances Act]《管制物质法》
current chemistry, manufacturing and controls 现行化学、生产和控制
Current Good Manufacturing Practice 现行良好生产规范
Customs and Border Protection 美国海关和边境保护局
CVM [=Center for Veterinary Medicine]FDA的兽药中心
cystic fibrosis 囊性纤维性变病
Cystic Fibrosis Foundation 囊肿性纤维化基金会
dairy cattle 奶牛
Data Safety and Monitoring Boards 数据安全和监测委员会
data safety monitoring board 数据安全监测委员会
DEA [=Drug Enforcement Administration]毒品强制执法局
declaratory 宣告性
decorative contact lenses 装饰性隐形眼镜
Definition of Primary Mode of Action of a Combination Product 《复合产品首要作用模式的定义》
dementia 痴呆
Department of Homeland Security 国土安全部
Department of Justice 司法部
DESI [=Drug Efficacy Study Implementation process]药效研究实施程序
detail opportunities 选派机会
detain 暂扣
detention order 扣留令
Development and Use of Risk Minimization Action Plans 《风险最小化行动计划的制定与使用》
DHA [=docosahexaenoic acid]二十二碳六烯酸
DHS [=Department of Homeland Security]国土安全部
diabetic peripheral neuropathy 糖尿病性周围神经病变
diabetic test strips 糖尿病测试条
Diagnosis and Management of Foodborne
Illnesses: A Primer for Physicians and Other Health Care Professionals
食源性疾病的诊断和管理:给内科医生和其它医疗保健专业人士的读本
Dietary Supplement Health and Education Act 《饮食补充剂健康和教育法》
dietary supplements 饮食补充剂
directed donor 指定供体
Directions for Use 用法说明
directives 指令
display box 纸板陈列盒
dissolvable stitches 可降解医用手术缝线
distorted vision 视物变形
distributor 分销商
district office 地区办公室
diversion 流弊(转入非法渠道)
Division of Dockets Management 文档管理部
docosahexaenoic acid 二十二碳六烯酸
domperidone 多潘立酮
dopamine agonist 多巴胺促效剂
dose-response 剂量反应
double-blind controlled studies 双盲对照试验
Draft Guidance for Industry and FDA
Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment
《用于行业和FDA工作人员的指南草案;用于减少被困事故的医院病床系统尺度指南》
drug application review performance goals 药品申请绩效目标
Drug Efficacy Study Implementation process 药效研究实施程序
Drug Enforcement Administration 毒品强制执法局
drug regimen information 药品使用信息
drug ring 药品集团
drug-eluting stents 药物释放支架
DSHEA [=Dietary Supplement Health and Education Act]《饮食补充剂健康和教育法》
dyskinesias 运动障碍
Educational Primer 教育性读本
EGFR [=pidermal growth factor receptor]表皮生长因子受体
eiscosapentaenoic acid 二十碳五烯酸
electronic submission 电子提交物
electrophysiology catheters 电生理导管
Eligibility Determination for Donors of
Human Cells, Tissues, and Cellular and Tissue-Based Products
《关于人类细胞、组织以及细胞的和基于组织的产品的供体的合格测定》
end-of-dose wearing off 剂末折磨
endometrial cancer 子宫内膜癌
endoscopic/laparoscopic instruments 内窥镜/腹腔镜检查装置
endothelial cells 内皮细胞
enforcement discretion 执行决定
enrollment form 登记表
entrapment 被困
environmental sample 环境样品
EPA [=eiscosapentaenoic acid]二十碳五烯酸
ephedra 麻黄
ephedrine alkaloids 麻黄碱
estrogen 雌激素
Estrogen-Alone Therapy 雌激素单独疗法
evidence-based reviews 循证审查
excessive sleepiness 嗜睡
exclusive marketing 市场独占权
executive level 执行级别
exocrine pancreatic insufficiency disorder 胰外分泌功能不全症
Expedited Review Process 加快审查程序
expiration dates 失效日期
export certificates 出口证书
export certification 出口认证
exposure assessments 影响评估
express consignment operator 快件货物操作员
extended release pain medication 延释型止痛药物
extended-release formulation 延释制剂
external genital warts 外生殖器疣
extortion plot 勒索阴谋
extra label “特别标签”
facial wasting 脸部消瘦
false or misleading claims 虚假或误导的声称
farm-to-table 从农场到餐桌
farmers markets 农场主市场
Fast-Track Status 快速通道待遇
FBI [=Federal Bureau of Investigation]联邦调查局
FCC [=Forensic Chemical Center]法医化学中心
FDA District Director FDA地区主任
FDAs Office of Womens Health FDA妇女健康办公室
FDA/NCI Interagency Oncology Task Force FDA/NCI机构间肿瘤学工作组
Federal Bureau of Investigation 联邦调查局
Federal e-Rulemaking Portal 联邦电子规章制定端口
Federal Measures to Mitigate BSE Risks: Considerations for Further Action 《减轻疯牛病风险的联邦措施:进一步行动的考虑》
Federal Register 《联邦登记薄》
federal risk disclosure rules 联邦风险公开规则
filers 文件编档者
film-coated tablet 膜衣片剂
financial holdings 财产
first-line treatment 一线治疗药物
fixed dose combination 固定剂量组方
fixed-dose combination 固定剂量组方
flu season 流感季节
fluid retention 体液渚留
focused ultrasound 聚焦超声
follow- up 随访
Food Advisory Committee 食品顾问委员会
Food Allergen Labeling and Consumer Protection Act 《食品过敏原标识和消费者保护法》
food allergens 食物过敏源
food allergies 食物过敏症
food contact substances 食品接触物质
Food GMP Modernization Working Group 食品GMP现代化工作组
Food Safety Inspection Service 美国农业部食品安全检查局
Food, Drug, and Cosmetic Act 《食品、药品和化妆品法》
food-associated crisis- and incident-management activities 食品相关危机和事故管理活动
foodborne illness 食源性疾病
foodborne pathogens 食源性病原体
Forensic Chemical Center 法医化学中心
formulation 配方
frown lines 皱眉纹
FSIS [=Food Safety Inspection Service]美国农业部食品安全检查局
full-time staff 专职员工
functional performance 功能特性
gall bladder disease 胆囊疾病
Gastrointestinal Drugs Advisory Committee 胃肠道药物咨询委员会
gastrointestinal perforation 胃肠穿孔
general laparoscopic gall bladder surgery 普通腹腔镜胆囊手术
general non-cardiac thoracoscopic chest surgery 普通非心脏的胸膜腔镜胸外科手术
generally recognized as safe substances 通常被认为安全的物质
generic drug 通用名药
generic equivalents 通用名的相等物
Genetic Modification Clinical Research Information System, GeMCRIS 基因修正临床研究信息系统
glazed ceramic vessels 陶瓷器皿
good agricultural and management practices 良好农业与管理规范
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment 良好药物警戒规范和药物流行学评估》
government-wide Bio-Surveillance Initiative *层面的生物监视行动
GRAS substances [=generally recognized as safe substances]通常被认为安全的物质
Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV 《关于固定剂量组方和组合包装的HIV治疗药品的行业指南》
Guidance for Industry:Eligibility
Determination for Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products 《行业指南:关于人类细胞、组织以及细胞的和基于组织的产品的供体的合格测定》
Guidance for Industry:Prior Notice of Imported Food Contingency Plan for System Outages 行业指南:系统出错时进口食品事先通告的应急计划
Guidance for the Clinical Evaluation of Weight-Control Drugs 《体重控制药物临床评价指南》
Guillain-Barr syndrome 急性多神经根炎
guilty pleas 有罪抗辩
HACCP [=Hazard Analysis and Critical Control Point]危害分析与关键控制点
hanger bar 吊架杆
Hazard Analysis and Critical Control Point 危害分析与关键控制点
HCT/Ps [=Eligibility Determination for
Donors of Human Cells, Tissues, and Cellular and Tissue-Based
Products]《关于人类细胞、组织以及细胞的和基于组织的产品的供体的合格测定》
HDE [=Humanitarian Device Exemption]人道主义器械豁免
health professional labeling 医护人员标识
Health Resources and Services Administration 健康资源与服务管理局
healthcare costs 医疗保健费用
healthcare facilities 医疗保健机构
hearing aids 助听器
heart attack 心肌梗死
hereditary tyrosinemia 遗传性酪氨酸血症
high-risk devices 高风险器械
Hispanic community 拉丁美洲裔社区
HIV test kit HIV检测盒
homecare providers 家庭护理人员
homocystinuria 高胱氨酸尿症
hormone implants 激素埋植剂
hormone refractory prostate cancer 激素抵抗性前列腺癌
hormone therapy 激素疗法
hormone therapy for menopausal symptoms 更年期症状激素治疗
Hospital Bed Safety Work Group 医院病床安全工作组
hot flashes 潮红
House Government Reform Committee Chairman 众议院*改革委员会
HRSA [=Health Resources and Services Administration]健康资源与服务管理局
Human Gene Transfer Research Data System 人类基因转移研究数据系统
Humanitarian Device Exemption 人道主义器械豁免
hurricane 飓风
hyaluronidase for injection 注射用透明质酸酶
hypercalcemia 高钙血征
Hyperparathyroidism 甲状旁腺功能亢进症
hyperthyroidism 甲状腺机能亢进
hypoglycemia 低血糖
hysterectomy 子宫切除
IBS [=irritable bowel syndrome]肠应激综合征
idiosyncratic aplastic anemia 特异反应性再生障碍性贫血
IFR [=prior notice interim final rule]事先通告暂行最终规则
ILD [=interstitial lung disease]间质性肺炎
imaging agents 成像剂
immobility 患者不动性
immune- compromised 免疫受损的
impaired wound healing 伤口愈合不良
implanted lens 植入型透镜
Import Alert 进口警报
in-vitro diagnostic kits 体外诊断盒
inborn errors of metabolism 先天性代谢缺陷
incarceration 监禁
Independent Cosmetic Manufacturers and Distributors, Inc. 独立的化妆品生产商与销售商社团
influenza vaccination 流感疫苗接种
infomercials 商业信息片
Information Analysis and Infrastructure Protection DHS信息分析及基础设施保护组
Information for the Patient 患者使用信息
information sheet 信息单
informed decision 知情决定
infrastructure 基层设施
ingredient statements 成份声明
ingredients statement 成份说明
injectable filler 注射型填充剂
injunctive 指令性
inspectional oversight 检查性监督
Institutional Biosafety Committees 机构生物安全委员会
Institutional Review Boards 机构审查委员会
institutional trays 机构用托盘
integrated approach 综合方法
integrated federal-state response plans 联邦-州响应计划
inter-center coordinating group 中心间协调小组
Interim Procedures for Qualified Health
Claims in the Labeling of Conventional Human Food and Human Dietary
Supplements 关于传统人类食品和人类饮食补充剂的标签中限制性健康声称的暂行程序
International Conference on Harmonization of the Technical Requirements for Registration of Pharmaceuticals 国际药品注册技术要求协调会
International Cooperation on
Harmonization of Technical Requirements for Registration of Veterinary
Medicinal Products 国际兽药产品注册技术要求协调合作会
international review team 国际审查组
interstitial lung disease 间质性肺炎
intraocular lens 眼内透镜
IOL [=intraocular lens]眼内透镜
irritable bowel syndrome 肠应激综合征
IRT [=international review team]国际审查组
isovaleric acidemia 异戊酸酸血症
joint FDA-FSIS Food Emergency Response Network of laboratories 联合的实验室的FDA-FSIS食品紧急事件反应网络
L- dopa 左旋多巴
lactation 泌乳
laser surgery 激光手术
LASIK 激光原位角膜磨镶术
launder money 洗钱
laying hens 产蛋鸡
Legal Aid 法律援助
lipoatrophy 皮下脂肪萎缩
liquidated damages 违约赔偿金
listeria 李斯特菌
liver cirrhosis 肝硬化
lung nodules 肺结核
machine-readable 机读
magnetic resonance imaging 磁共振成像
malignant pleural mesothelioma 恶性胸膜间皮瘤
mammalian protein 哺乳动物蛋白
mandatory reporting 责任通报
manufacturing facility 生产设施
manufacturing quotas 生产配额
maple syrup urine disease 槭糖尿病
Master of Science in Nursing 护理学硕士
MCAD [=medium chain Acyl-CoA dehydrogenase deficiency]中链脂酰辅酶A脱氢酶缺乏
MDIs [=albuterol metered-dose inhalers]沙丁胺醇定量吸入器
meat inspection system 肉类检查系统
meat-based products 基于肉的制品
mechanical sling-like devices 机械性似吊机的器械
mechanically separated beef 机械分割的牛肉
MedGuide [=Patient Medication Guide]患者药物治疗指南
Medical Device User Fee and Modernization Act (MDUFMA) 《医疗器械用户收费和现代化法》
medical imaging 医学成像
medical practitioner 执业医师
Medicare improvement act 《医疗保险改良法》
Medicare prescription drug benefit “医疗保险处方药益处”
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ,MMA 《2003年医疗保险处方药、改良和现代化法》
medicinal leeches 药用水蛭
Medicines and Healthcare Products Regulatory Agency, MHRA 英国药品与医疗保健产品监管局
medium chain Acyl-CoA dehydrogenase deficiency 中链脂酰辅酶A脱氢酶缺乏
menopause 更年期
metadata 元数据
Methylmercury 甲基汞
Mexican Americans 墨西哥裔美国人
mild cognitive impairment 轻度认知缺损
miniaturized heart pump 小型化的心脏泵
minimally-manipulated bone marrow 最低限度处理的骨髓
Minor Use and Minor Species Animal Health Act 《较少使用及较少物种动物健康法》
Minor Use and Minor Species Animal Health Act of 2003 《2003年较少使用和少数种动物健康法》
misbranded 标识错误
mislabeled 错误标识的
misstatements 虚伪声明
mitigation measures 减轻措施
mitral valve repair 二尖瓣修补术
monoclonal antibodies 单克隆抗体
monthly newsletters 每月通讯
Montreal Protocol on Substances that Deplete the Ozone Layer 《关于消耗臭氧层物质的蒙特利尔议定书》
MRI [=magnetic resonance imaging]磁共振成像
MSN [=Master of Science in Nursing]护理学硕士
MSUD [=maple syrup urine disease]槭糖尿病
MUMS [=Minor Use and Minor Species Animal Health Act]《较少使用及较少物种动物健康法》
Myelodysplastic Syndrome, MDS 骨髓增生异常综合症
narcotic 麻醉性的
NASDA [=National Association of State Departments of Agriculture]州农业部全国协会
National Alliance for Hispanic Health 全国西班牙语健康联盟
national animal identification system 全国性动物识别系统
National Association of Boards of Pharmacy 全国药房委员会协会
National Association of State Departments of Agriculture 州农业部全国协会
National Collegiate Athletic Association 全国大学生体育协会
National Community Pharmacists Association 全国社会药师协会
National Council on the Aging 美国国家老龄理事会
National Critical Path Opportunities List 全国关键性通道机会清单
National Drug Code number 国家药品代码号
National Drug Control Strategy 国家毒品管制战略
National Football League 国家橄榄球联盟
National Institute on Drug Abuse 国家药物滥用研究所
National Menopause Awareness Month 全国妇女更年期认知月
National Press Club 全国记者俱乐部
National Womens Health Information Center 美国国家妇女健康信息中心
Nationwide Consumer Alert 全国性消费者警报
natural lens 自然晶状体
NCAA [=National Collegiate Athletic Association]全国大学生体育协会
NCPA [=National Community Pharmacists Association]全国社会药师协会
NDAs [=new drug applications]新药申请
Neuropathic Pain 神经性疼痛
neurotoxin 神经毒素
New Drug Applications 新药申请
new molecular entity 新分子实体
Newsmaker Luncheon 新闻工作者午宴
NFL [=National Football League]国家橄榄球联盟
night sweats 盗汗
non-administrative employees 非行政雇员
non-invasive therapy 非损伤性治疗
Non-Public Records/Information 非公开记录/信息
non-steroidal anti-inflammatory drug 非甾体抗炎药
norovirus 诺沃克类病毒
not approvable letters 不可批准函
not substantially equivalent 不能在实质上等同
notice-and-comment “通告和意见”
NSAID [=non-steroidal anti-inflammatory drug]非甾体抗炎药
NSE [=not substantially equivalent]不能在实质上等同
nursing homes 疗养院
Nutrition Facts panel “营养事实”表
NWHIC [=National Womens Health Information Center]美国国家妇女健康信息中心
OFAS [=Office of Food Additive Safety]食品添加剂安全办公室
Office of Cellular, Tissue and Gene Therapies CBER细胞、组织和基因疗法办公室
Office of Criminal Investigations FDA犯罪调查办公室
Office of Food Additive Safety 食品添加剂安全办公室
Office of Government Ethics *伦理办公室
Office of Legislation FDA立法办公室
Office of National Drug Control Policy 国家毒品管制政策办公室
Office of New Drug Chemistry 新药化学办公室
Office of Nutritional Products, Labeling and Dietary Supplements CFSAN的营养产品、标识和膳食补充剂办公室
Office of Oncology Drug Products 肿瘤学药品办公室
Office of Public Affairs FDA公共事务办公室
Office of Special Health Issues 特殊健康问题办公室
Office of the Ombudsman 监察专员办公室
oily fish 富含脂肪的鱼
omega-3 fatty acids ω-3脂肪酸
on/off motor fluctuations 开通/关闭运动神经波动
OPD [=Office of Oncology Drug Products]肿瘤学药品办公室
open-label registry study 公开标签登记研究
operator 经营商
Ophthalmic Devices Panel of FDAs Medical Devices Advisory Committee FDA医疗器械顾问委员会眼科器械专家组
opioid pain killers 阿片类止痛药
opioid- tolerant 阿片耐受型
oral fluid 口液
Orphan Drug Act 《罕见病药物法》
orphan product 罕见病治疗产品
orthopedic implants with genetically engineered human protein 基因工程人体蛋白的整形外科埋植剂
osteoarthritis 骨关节炎
osteoporosis 骨质疏松
outcome 预后
overarching goal 全局目标
overdose 用药过量
overlapping toxicities 交叉毒性
ozone-depleting propellants 含耗臭氧喷射剂
ozone- depleting substance,ODS 含耗臭氧物质
pacifier 安抚奶嘴
pain relievers 镇痛剂
pancrealipase 胰脂肪酶
pancreatic enzyme 胰酶
pancreatic extract 胰脏提取物
pancreatic insufficiency products 胰功能不全制品
Parathyroid Cancer 甲状旁腺癌
Parkinson’s 帕金森氏综合症
partial artificial heart 局部人工心脏
PAT [=Process Analytical Technology]工艺分析技术
patient information sheet 患者信息表
patient lift devices 患者提升器械
Patient Medication Guide 患者药物治疗指南
PDMA [=Prescription Drug Marketing Act]《处方药销售法》
PDUFA [=Prescription Drug User Fee Act of 1992]《1992年处方药用户收费法》
PDUFA III [=Prescription Drug User Fee Amendments of 2002]《2002年处方药用户收费修正案》
Pediatric Drugs Advisory Committee 儿科药品咨询委员会
pedigree “谱系”
peer-reviewed journal 专家审查刊物
Percent Daily Value 日需百分率
Percent of Daily Value 日值百分数
performance standards 操作标准
peripheral neuropathy 外周神经病
Permanent Injunction 永久禁令
permanent injunctive relief 永久性禁令救济
petition review processes 申请审查工作
Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach;Final Report—Fall 2004 《21世纪的药品现行良好制造规范——一种基于风险的措施;最终报告——2004年秋》
Pharmaceutical Inspection Cooperation Scheme 药品检查合作计划
pharmaceutical quality assessment system 药品质量评估体系
pharmacy regulatory officials 药房监管人员
phendimetrazine 苯甲曲秦
phenylketonuria 苯丙酮尿症
physician labeling 医师用标签
pidermal growth factor receptor 表皮生长因子受体
pilot 小规模试验
pilot implementation 试验性应用
PKU [=phenylketonuria]苯丙酮尿症
placebo 安慰剂
Plan B emergency contraception product 计划B紧急避孕产品
plea agreement 抗辩协议
Point-of-care test “床边检测”
Policy Coordinating Council 政策协调委员会
porcine insulin zinc suspension product 猪胰岛素锌悬浮液产品
post marketing experience 上市后经验
potency 效能
poultry houses 禽舍
powdered beverage 饮料粉冲泡饮料
powdered formulas 配方奶粉
preapproval 预先批准
preliminary injunction 预先的法院指令
preliminary injunction order 预先的禁令
Premarketing Risk Assessment 《上市前风险评估》
Prescription Drug Marketing Act 《处方药销售法》
Prescription Drug User Fee Act 《处方药用户收费法》
Prescription Drug User Fee Act of 1992 《1992年处方药用户收费法》
Prescription Drug User Fee Amendments of 2002 《2002年处方药用户收费修正案》
Prescription Monitoring Programs 处方监视项目
Presidents Emergency Plan for AIDS Relief 总统AIDS救济紧急计划
primary axillary hyperhidrosis 原发性腋窝多汗症
prior notice interim final rule 事先通告暂行最终规则
Priority Review 优先审查
probation 缓刑
Process Analytical Technology 工艺分析技术
product package insert 产品包装说明书
professional associations 专业协会
progestin 孕酮
prohibited act 被禁止的行为
Project BioShield 生物盾计划
prolactin 催乳素
proposed rule 提议的规则
prosecution 诉讼
protein drug products 蛋白质药品
proteomics 蛋白质组学
Providing Regulatory Submissions in
Electronic Format--Human Pharmaceutical Applications and Related
Submissions 《以电子格式进行规范报送──人用药申请及相关报送》
Psychopharmacologic Drugs Advisory Committee 精神药理学药品咨询委员会
Public Health Security and Bioterrorism Preparedness and Response Act of 2002 《2002年公众健康安全和生物恐怖活动防范与应对法》
public trust 公信规则
pullets 小母鸡
qualified health claims 限制性健康声称
quality control procedures 质量控制规程
Quality System regulation 质量体系规章
Question Guide “问题指南”
questionnaire 问卷
radiation dispersal device 放射性散布装置
Ranking Member 高级官员
ransovarian contamination 经卵巢的污染
raw alfalfa sprouts 生紫花苜蓿芽菜
RDD [=radiation dispersal device]放射性散布装置
ready-to-eat 食类食品
reattachment surgery 复置术
recombinant DNA biotechnology 重组DNA生物技术
recombinant therapeutic proteins 重组治疗性蛋白
Recordkeeping Requirements for Human
Food and Cosmetics Manufactured From, Processed With, or Otherwise
Containing, Material From Cattle
《对由牛源性材料生产、加工或以其他方式含牛源性材料的人用食品与化妆品的记录保存要求》
referral procedure 引证程序
refill 补加(处方)
reflux disease surgery 反流病手术
registered nurse 注册护士
registration number 登记号
rehydrating agents 再水合剂
rehydration 重新补水
release rate 释放率
Renal Failure 肾衰竭
rendering facility 加工机构
rendering materials 副产品材料
repackager 重新包装商
reprocessed single-use devices 经再加工的一次性使用器械
Request for Approval of Outside Activity “对外部活动的批准请求”
Requirements Pertaining to Sampling
Services and Private Laboratories Used in Connection With Imported Food
《关于用于与进口食品有关的抽样机构和私人实验室的规定》
responsiveness 应答性
restricted devices 受限制器械
retail establishments 零售场所
retinal detachment 视网膜剥离
return policy “退还政策”
Review Template Initiative 审查模板行动
risk information window “风险信息窗口”
risk management 风险管理
risk management program 风险管理程序
risk-based BSE inspections 基于风险的BSE检查
RMP [=risk management program]风险管理程序
RN [=registered nurse]注册护士
RNA trans-splicing 核糖核酸反式剪接
roadside stands 路边摊
robotic-like device 机器人器械
ruminant product 反刍动物制品
safe consumer handling labeling and egg refrigeration and retail rule of 2000 2000年安全消费者处理标签和蛋类冷藏及零售规则
Salmonella Enteritidis 肠炎沙门氏菌
salmonellosis 沙门氏菌病
SARS [=Severe Acute Respiratory Syndrome]严重急性呼吸器官综合症
sBCC [=superficial basal cell carcinom]浅表性基底细胞癌
scoliosis 脊柱侧凸
SDTM [=Study Data Tabulation Model]试验数据表格样式
SE [=Salmonella Enteritidis]肠炎沙门氏菌
SEC [=Securities and Exchange Commission]美国证券交易委员会
Secretarial Summit on Health Information HHS部长健康信息峰会
Securities and Exchange Commission 美国证券交易委员会
sedatives 镇静剂
seizure warrant 查封令
Senior Advisor for Special Projects 特别项目资深顾问
sepsis 脓毒症
serving size 份餐量
Severe Acute Respiratory Syndrome 严重急性呼吸器官综合症
severe left ventricle failure 严重左心室衰竭
severe underarm sweating 严重腋下出汗
severe-to- profound 重度至极度
sexually intimate partner 亲密性伙伴
shared exclusivity 共享专卖权
shell egg 带壳蛋
shipment lot 货运批次
sign 征兆
single dosage 单一用药剂量
skin grafts 皮肤移植
sling 悬带
solid nodules 实质型结核
specific thresholds 特定阈值
specification 规范
specified risk materials 特定风险材料
spinal cord 脊髓
split decision 非一致性决定
SRMs [=specified risk materials]特定风险材料
Staff Manual Guide 员工指南手册
stakeholder 利益相关者
standard format 标准格式
Standards of Ethical Conduct 《伦理行为标准》
Statement Identifying Pharmaceutical Sale 鉴别药品销售的声明
statutory authorities 法定权力
stent system 动脉支架系统
sternotomy 胸骨切开术
stimulants 兴奋剂
strabismus 斜视
street drug alternatives 街头药物替代物
stroke 中风
Study Data Tabulation Model 试验数据表格样式
Sublingual Sensor 舌下传感器
submitters 提交者
substantial equivalence 实质等同性
sudden cardiac arrest 心搏骤停
SUDs [=reprocessed single-use devices]经再加工的一次性使用器械
suicidality 自杀
superficial basal cell carcinom 浅表性基底细胞癌
supervised release 受监督的释放
Supplemental Standards of Ethical Conduct Regulations 《伦理行为规章的补充标准》
system downtime scenarios 系统故障情况
table egg market 食用蛋市场
tabletop exercises 桌面演练
target viral assays 靶病毒测试法
Task Force on Drug Importation 药品进口工作组
tattooing 文身
Team Biologics Operations Group 小组生物制品工作组
technical consultation 技术磋商
therapeutic biologics 治疗用生物制品
therapeutic equivalents 疗效相等物
Thoracic Insufficiency Syndrome 胸机能不全综合症
thoracoscopically-assisted cardiotomy procedures 胸膜腔镜辅助的心切开术
thoracotomy 胸廓切开术
threat assessments 威胁评估
time frames 时间框架
Tissue Safety System 组织安全系统
toll-free number 免费电话号码
topical products 局部用产品
toxoplasma 弓形体
tranquilizers 镇定剂
transmitters 转运者
Trilateral Cooperation Charter 《三边合作宪章》
tropical storm 热带风暴
tubulin 微管蛋白
U.S. Clean Air Act 《美国清洁空气法》
U.S. Marshals Service 联邦警察局
U.S. Marshal’s Service 联邦执法局
U.S. postmarketing use data 联邦售后使用数据
U.S.-manufactured drugs 美国造药品
Under Secretary 副部长
underreport 漏报
undertreated 治疗不足
unique anti-HIV medications 单方抗HIV药物
Unit of Use 使用单位
United States Attorney 联邦检察官
United States Constitution 《联邦宪法》
United States Marshals 联邦警察
United States Postal Inspection Service 联邦邮政检查局
usability testing 可用性试验
Use of Materials Derived From Cattle in Human Food and Cosmetics 《牛源性材料在人用食品与化妆品中的使用》
user fee performance goals 用户收费绩效目标
user fee waivers 用户收费弃权
USPIS [=United States Postal Inspection Service]联邦邮政检查局
vaginal dryness 阴道干燥
valid exclusivity claims 有效的专卖权声称
validity 有效性
variant Creutzfeldt-Jakob disease 变异的克雅氏病
vascular endothelial growth factor 血管内皮生长因子
veal calves 小肉牛
VEGF [=vascular endothelial growth factor]血管内皮生长因子
ventilator 呼吸器
Vermont State Employee Medical Benefit Plan,VSEMBP 佛蒙特州雇员医疗福利计划
Vertical Expandable Prosthetic Titanium Rib 垂直可扩张的修复性钛肋骨
Veterans Affairs Medical Center 退伍军人医疗中心
Vioxx Gastrointestinal Outcomes Research Vioxx胃肠结果研究
visual impairment 视觉损伤
vulnerability 易感性
washer 垫圈
water-purifying tablets 净化水的片剂
web crawler/data mining technology 网络搜索器/数据挖掘技术
weight loss 减肥
weight loss stimulant 减肥兴奋剂
West Nile virus 西尼罗河病毒
WHI [=Womens Health Initiative]妇女健康行动计划
whole organs 全器官
Womens Health Initiative 妇女健康行动计划
workshops 专题研讨会
xenotransplantation 异种移植
youth-oriented organizations 青年导向组织
“180-day exclusivity” periods “180天专卖权”期间
“authorized generic” versions “经认可的通用”版
“Drug Facts” label “药品事实“标签
“essential-use” status “必需使用”地位
1992年处方药用户收费法 Prescription Drug User Fee Act of 1992,PDUFA
2000年安全消费者处理标签和蛋类冷藏及零售规则 safe consumer handling labeling and egg refrigeration and retail rule of 2000
2002年处方药用户收费修正案 Prescription Drug User Fee Amendments of 2002,PDUFA III
2002年公共健康安全和生物恐怖防备应对法 Public Health Security and Bioterrorism Preparedness and Response Act of 2002
2002年公众健康安全和生物恐怖活动防范与应对法 Public Health Security and Bioterrorism Preparedness and Response Act of 2002
2003年变态反应原标识和消费者保护法 Allergen Labeling and Consumer Protection Act
2003年较少使用和少数种动物健康法 Minor Use and Minor Species Animal Health Act of 2003
2003年医疗保险处方药、改良和现代化法 Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ,MMA
2004 历年 calendar year 2004
21世纪的药品现行良好制造规范--一种基于风险的措施;最终报告--2004年秋 Pharmaceutical cGMPs for the 21st Century-A Risk-Based Approach;Final Report-Fall 2004
A型肉毒杆菌毒素 Botulinum Toxin Type A
CBER细胞、组织和基因疗法办公室 Office of Cellular, Tissue and Gene Therapies
CFSAN的营养产品、标识和膳食补充剂办公室 Office of Nutritional Products, Labeling and Dietary Supplements
DHS 信息分析及基础设施保护组 Information Analysis and Infrastructure Protection
FDA/NCI 机构间肿瘤学工作组 FDA/NCI Interagency Oncology Task Force
FDA备忘录管理处 Division of Dockets Management
FDA的兽药中心 Center for Veterinary Medicine,CVM
FDA 地区主任 FDA District Director
FDA犯罪调查办公室 Office of Criminal Investigations
FDA妇女健康办公室 FDAs Office of Womens Health
FDA公共事务办公室 Office of Public Affairs
FDA立法办公室 Office of Legislation
FDA医疗器械顾问委员会眼科器械专家组 Ophthalmic Devices Panel of FDAs Medical Devices Advisory Committee
HHS部长健康信息峰会 Secretarial Summit on Health Information
HIV 检测盒 HIV test kit
Vioxx胃肠结果研究 Vioxx Gastrointestinal Outcomes Research
“180 天专卖权”期间 “180-day exclusivity” periods
“必需使用”地位 “essential-use” status
“经认可的通用”版 “authorized generic” versions
“药品事实”标签 ‘Drug Facts’ label
“营养事实”表 "Nutrition Facts" panel
《1992年处方药用户收费法》 Prescription Drug User Fee Act of 1992,PDUFA
《2002年处方药用户收费修正案》 Prescription Drug User Fee Amendments of 2002,PDUFA III
《2002年公共健康安全和生物恐怖防备应对法》 Public Health Security and Bioterrorism Preparedness and Response Act of 2002
《2002 年公众健康安全和生物恐怖活动防范与应对法》 Public Health Security and Bioterrorism Preparedness and Response Act of 2002
《2003年变态反应原标识和消费者保护法》 Allergen Labeling and Consumer Protection Act
《2003年较少使用和少数种动物健康法》 Minor Use and Minor Species Animal Health Act of 2003
《2003年医疗保险处方药、改良和现代化法》 Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ,MMA
《21世纪的药品现行良好制造规范--一种基于风险的措施;最终报告--2004年秋》 Pharmaceutical cGMPs for the 21st Century-A Risk-Based Approach;Final Report-Fall 2004
《处方药销售法》 Prescription Drug Marketing Act,PDMA
《处方药用户收费法》 Prescription Drug User Fee Act
《对由牛源性材料生产、加工或以其他方式含牛源性材料的人用食品与化妆品的记录保存要求》
Recordkeeping Requirements for Human Food and Cosmetics Manufactured
From, Processed With, or Otherwise Containing, Material From Cattle
《风险最小化行动计划的制定与使用》 Development and Use of Risk Minimization Action Plans
《复合产品首要作用模式的定义》 Definition of Primary Mode of Action of a Combination Product
《根据〈2002年公众健康安全保障和生物恐怖活动防范与应对法〉用于人或动物消费的食品的行政扣留》
Administrative Detention of Food for Human or Animal Consumption Under
the Public Health Security and Bio-terrorism Preparedness and Response
Act of 2002
《关键性通道机遇目录》 Critical Path Opportunities List
《关于固定剂量组方和组合包装的HIV治疗药品的行业指南》 Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV
《关于人类细胞、组织以及细胞的和基于组织的产品的供体的合格测定》
Eligibility Determination for Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products[HCT/Ps]
《关于消耗臭氧层物质的蒙特利尔议定书》 Montreal Protocol on Substances that Deplete the Ozone Layer
《关于用于与进口食品有关的抽样机构和私人实验室的规定》
Requirements Pertaining to Sampling Services and Private Laboratories
Used in Connection With Imported Food
《管制物质法》 Controlled Substances Act ,CSA
《罕见病药物法》 Orphan Drug Act
《简明摘要:在面向消费者的印刷广告中公开风险信息》 Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements
《减轻疯牛病风险的联邦措施:进一步行动的考虑》 Federal Measures to Mitigate BSE Risks: Considerations for Further Action
《较少使用及较少物种动物健康法》 Minor Use and Minor Species Animal Health Act,MUMS
《联邦登记薄》 Federal Register
《联邦宪法》 United States Constitution
《伦理行为标准》 Standards of Ethical Conduct
《伦理行为规章的补充标准》 Supplemental Standards of Ethical Conduct Regulations
《美国清洁空气法》 U.S. Clean Air Act
《牛源性材料在人用食品与化妆品中的使用》 Use of Materials Derived From Cattle in Human Food and Cosmetics
《三边合作宪章》 Trilateral Cooperation Charter
《上市前风险评估》 Premarketing Risk Assessment
《食品、药品和化妆品法》 Food, Drug, and Cosmetic Act
《食品过敏原标识和消费者保护法》 Food Allergen Labeling and Consumer Protection Act
《兽药用户收费法》 Animal Drug User Fee Act
《体重控制药物临床评价指南》 Guidance for the Clinical Evaluation of Weight-Control Drugs
《行业指南:关于人类细胞、组织以及细胞的和基于组织的产品的供体的合格测定》
Guidance for Industry:Eligibility Determination for Donors of Human
Cells, Tissues, and Cellular and Tissue-Based Products[HCT/Ps]
《行政程序法》 Administrative Procedure Act
《医疗保险改良法》 Medicare improvement act
《医疗器械用户收费和现代化法》 Medical Device User Fee and Modernization Act (MDUFMA)
《以电子格式进行规范报送──人用药申请及相关报送》 Providing
Regulatory Submissions in Electronic Format--Human Pharmaceutical
Applications and Related Submissions
《饮食补充剂健康和教育法》 Dietary Supplement Health and Education Act[DSHEA]
《用于批准的上市新药申请;完全回应函;对未批准申请的修正》
Applications for Approval to Market a New Drug; Complete Response
Letter; Amendments to Unapproved Applications
《用于行业和FDA工作人员的指南草案;用于减少被困事故的医院病床系统尺度指南》
Draft Guidance for Industry and FDA Staff; Hospital Bed System
Dimensional Guidance to Reduce Entrapment
ω- 3脂肪酸 omega-3 fatty acids
阿片类止痛药 opioid pain killers
阿片耐受型 opioid- tolerant
安抚奶嘴 pacifier
安慰剂 placebo
案例研究 case studies
靶病毒测试法 target viral assays
白内障 cataract
被禁止的行为 prohibited act
被困 entrapment
苯丙酮尿症 phenylketonuria,PKU
苯甲曲秦 phendimetrazine
变异的克雅氏病 variant Creutzfeldt-Jakob disease
标识错误 misbranded
标准格式 standard format
表皮生长因子受体 pidermal growth factor receptor,EGFR
丙烯酰胺 acrylamide
拨款 appropriations
哺乳动物蛋白 mammalian protein
补加 refill
不可批准函 not approvable letters
不能在实质上等同 not substantially equivalent[NSE]
财产 financial holdings
操作标准 performance standards
查封令 seizure warrant
产蛋鸡 laying hens
产品包装说明书 product package insert
常见症状 common symptom
肠炎沙门氏菌 Salmonella Enteritidis,SE
肠应激综合征 irritable bowel syndrome [IBS]
潮红 hot flashes
成份声明 ingredient statements
成份说明 ingredients statement
成年牛 adult cattle
成像剂 imaging agents
承运人 consolidator
痴呆 dementia
出口认证 export certification
出口证书 export certificates
雏鸡 chicks
处方监视项目 Prescription Monitoring Programs
处方药销售法 Prescription Drug Marketing Act,PDMA
处方药用户收费法 Prescription Drug User Fee Act
传统食品 conventional foods
床边检测 Point-of-care test
垂直可扩张的修复性钛肋骨 Vertical Expandable Prosthetic Titanium Rib
磁共振成像 magnetic resonance imaging,MRI
雌激素 estrogen
雌激素单独疗法 Estrogen-Alone Therapy
从农场到餐桌 farm-to-table
从事复方的药房 compounding pharmacies
促合成代谢类固醇 anabolic steroid
催乳素 prolactin
错误标识的 mislabeled
带壳蛋 shell egg
代理酬金 commission
代理商 agent
单方抗HIV药物 unique anti-HIV medications
单克隆抗体 monoclonal antibodies
单一用药剂量 single dosage
胆囊疾病 gall bladder disease
蛋白质药品 protein drug products
蛋白质组学 proteomics
盗汗 night sweats
登记表 enrollment form
登记号 registration number
低血糖 hypoglycemia
地区办公室 district office
垫圈 washer
电生理导管 electrophysiology catheters
电子提交物 electronic submission
吊架杆 hanger bar
动脉支架系统 stent system
动物饲料禁令 animal feed ban
毒品强制执法局 Drug Enforcement Administration,DEA
独立的化妆品生产商与销售商社团 Independent Cosmetic Manufacturers and Distributors, Inc.
对外部活动的批准请求 Request for Approval of Outside Activity
对由牛源性材料生产、加工或以其他方式含牛源性材料的人用食品与化妆品的记录保存要求
Recordkeeping Requirements for Human Food and Cosmetics Manufactured
From, Processed With, or Otherwise Containing, Material From Cattle
多巴胺促效剂 dopamine agonist
多潘立酮 domperidone
恶性胸膜间皮瘤 malignant pleural mesothelioma
儿科药品咨询委员会 Pediatric Drugs Advisory Committee
耳蜗植入物 cochlear implants
二尖瓣修补术 mitral valve repair
二十二碳六烯酸 docosahexaenoic acid,DHA
二十碳五烯酸 eiscosapentaenoic acid,EPA
法定权力 statutory authorities
法律援助 Legal Aid
法医化学中心 Forensic Chemical Center,FCC
反流病手术 reflux disease surgery
反刍动物制品 ruminant product
放射性散布装置 radiation dispersal device [RDD]
放血 blood-letting
非法药物滥用类别 category of illicit drug abuse
非公开记录/信息 Non-Public Records/Information
非损伤性治疗 non-invasive therapy
非行政雇员 non- administrative employees
非一致性决定 split decision
非洲裔美国人 African Americans
非甾体抗炎药 non-steroidal anti-inflammatory drug,NSAID
肺结核 lung nodules
分销商 distributor
份餐量 serving size
风险管理 risk management
风险管理程序 risk management program,RMP
风险信息窗口 risk information window
风险最小化行动计划的制定与使用 Development and Use of Risk Minimization Action Plans
疯牛病确诊动物 BSE positive animal
佛蒙特州雇员医疗福利计划 Vermont State Employee Medical Benefit Plan,VSEMBP
氟氯化碳喷射剂 chlorofluorocarbon[CFC] propellants
副部长 Under Secretary
副产品材料 rendering materials
复合并发症 combined complication
复合产品首要作用模式的定义 Definition of Primary Mode of Action of a Combination Product
复置术 reattachment surgery
富含脂肪的鱼 oily fish
妇女健康行动计划 Womens Health Initiative,WHI
钙磷离子积 calcium x phosphorus ion product
肝硬化 liver cirrhosis
高风险的再加工一次性使用器械 critical reprocessed SUDs
高风险器械 high-risk devices
高钙血征 hypercalcemia
高级官员 Ranking Member
高胱氨酸尿症 homocystinuria
根据〈2002年公众健康安全保障和生物恐怖活动防范与应对法〉用于人或动物消费的食品的行政扣留
Administrative Detention of Food for Human or Animal Consumption Under
the Public Health Security and Bio-terrorism Preparedness and Response
Act of 2002
更年期 menopause
更年期症状激素治疗 hormone therapy for menopausal symptoms
工艺分析技术 Process Analytical Technology,PAT
功能特性 functional performance
公开标签登记研究 open-label registry study
公民申请书 Citizen Petitions
公信规则 public trust
弓形体 toxoplasma
共享专卖权 shared exclusivity
骨关节炎 osteoarthritis
骨髓抑制 bone marrow suppression
骨髓增生异常综合症 Myelodysplastic Syndrome, MDS
骨质疏松 osteoporosis
顾问委员会监督和管理机构 Advisory Committee Oversight and Management Staff
顾问组 advisory panel
固定剂量组方 fixed dose combination
关键性通道机遇目录 Critical Path Opportunities List
关键性通道行动 Critical Path initiative
关节炎顾问委员会 Arthritis Advisory Committee
关于传统人类食品和人类饮食补充剂的标签中限制性健康声称的暂行程序
Interim Procedures for Qualified Health Claims in the Labeling of
Conventional Human Food and Human Dietary Supplements
关于固定剂量组方和组合包装的 HIV治疗药品的行业指南 Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV
关于人类细胞、组织以及细胞的和基于组织的产品的供体的合格测定
Eligibility Determination for Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products[HCT/Ps]
关于消耗臭氧层物质的蒙特利尔议定书 Montreal Protocol on Substances that Deplete the Ozone Layer
关于用于与进口食品有关的抽样机构和私人实验室的规定 Requirements
Pertaining to Sampling Services and Private Laboratories Used in
Connection With Imported Food
冠心病 coronary heart disease,CHD
冠状动脉旁路手术 coronary artery by-pass surgery
管制物质 controlled substances
管制物质法 Controlled Substances Act ,CSA
光化性角化病 actinic keratosis
广谱抗生药 broad-spectrum antibiotic drug
规范 specification
国际审查组 international review team,IRT
国际兽药产品注册技术要求协调合作会 International
Cooperation on Harmonization of Technical Requirements for Registration
of Veterinary Medicinal Products,VICH
国际药品注册技术要求协调会 International Conference on Harmonization of the Technical Requirements for Registration of Pharmaceuticals,ICH
国家毒品管制战略 National Drug Control Strategy
国家毒品管制政策办公室 Office of National Drug Control Policy
国家药品代码号 National Drug Code number
国家药物滥用研究所 National Institute on Drug Abuse
国家橄榄球联盟 National Football League [NFL]
国土安全部 Department of Homeland Security,DHS
含耗臭氧喷射剂 ozone- depleting propellants
含耗臭氧物质 ozone-depleting substance,ODS
罕见病药物法 Orphan Drug Act
罕见病治疗产品 orphan product
核糖核酸反式剪接 RNA trans-splicing
核心食品 core foods
黑框 black box
黑框警告 black-box warning
呼吸器 ventilator
护理学硕士 Master of Science in Nursing,MSN
护理者 caregiver
化学个体 chemical entities
化学信使 chemical messenger
化妆品、化妆用具和香料协会 Cosmetic, Toiletry, and Fragrance Association
环境样品 environmental sample
缓刑 probation
患者不动性 immobility
患者使用信息 Information for the Patient
患者提升器械 patient lift devices
患者信息表 patient information sheet
患者药物治疗指南 Patient Medication Guide[MedGuide]
活度 activity
活组织检查 biopsy
货运批次 shipment lot
基层设施 infrastructure
基因工程人体蛋白的整形外科埋植剂 orthopedic implants with genetically engineered human protein
基因修正临床研究信息系统 Genetic Modification Clinical Research Information System, GeMCRIS
基于风险的BSE检查 risk-based BSE inspections
基于肉的制品 meat-based products
机读 machine-readable
机构审查委员会 Institutional Review Boards
机构生物安全委员会 Institutional Biosafety Committees
机构用托盘 institutional trays
机器人器械 robotic-like device
机械分割的牛肉 mechanically separated beef
机械性似吊机的器械 mechanical sling-like devices
稽查概要 compliance summary
稽查政策指南 compliance policy guide[CPG]
激光手术 laser surgery
激光原位角膜磨镶术 LASIK
激素抵抗性前列腺癌 hormone refractory prostate cancer
激素疗法 hormone therapy
激素埋植剂 hormone implants
急性多神经根炎 Guillain-Barr syndrome
疾病群 clusters
脊髓 spinal cord
脊柱侧凸 scoliosis
技术磋商 technical consultation
剂量反应 dose-response
剂末折磨 end-of-dose wearing off
计划B紧急避孕产品 Plan B emergency contraception product
计算机辅助检测 computer aided detection,CAD
计算机化系统 computerized systems
家庭护理人员 homecare providers
家庭健康理事会 Council on Family Health,CFH
加工机构 rendering facility
加快审查程序 Expedited Review Process
加拿大食品检验局 Canadian Food I, nspection Agency,CFIA
甲基汞 Methylmercury
甲壳类水生动物 crustacean shellfish
甲状旁腺癌 Parathyroid Cancer
甲状旁腺功能亢进症 Hyperparathyroidism
甲状腺机能亢进 hyperthyroidism
监察专员办公室 Office of the Ombudsman
监管问题总顾问助理 Assistant General Counsel for Regulatory Issues
监禁 incarceration
间质性肺炎 interstitial lung disease,ILD
检查性监督 inspectional oversight
简明摘要:在面向消费者的印刷广告中公开风险信息 Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements
减肥 weight loss
减肥兴奋剂 weight loss stimulant
减轻措施 mitigation measures
减轻疯牛病风险的联邦措施:进一步行动的考虑 Federal Measures to Mitigate BSE Risks: Considerations for Further Action
鉴别药品销售的声明 Statement Identifying Pharmaceutical Sale
健康资源与服务管理局 Health Resources and Services Administration,HRSA
建议的规章制定的事先通知 advance notice of proposed rulemaking,ANPR或ANPRM
交叉毒性 overlapping toxicities
交叉污染 cross contamination
交互中心动议工作组 Cross Center Initiatives Taskforce
角膜肿胀 corneal swelling
教育性读本 Educational Primer
较少使用及较少物种动物健康法 Minor Use and Minor Species Animal Health Act,MUMS
街头药物替代物 street drug alternatives
截肢术 amputation
戒酒 abstinence
进口警报 Import Alert
禁用 contraindicate
精神药理学药品咨询委员会 Psychopharmacologic Drugs Advisory Committee
经纪人 broker
经卵巢的污染 ransovarian contamination
经营商 operator
经再加工的一次性使用器械 reprocessed single-use devices[SUDs]
颈部张力障碍 cervical dystonia
颈动脉 carotid artery
颈动脉内膜剥离术 carotid endarterectomy
竞争源审查 competitive sourcing reviews
净化水的片剂 water-purifying tablets
酒精滥用 alcohol abuse
酒精依赖者 alcohol dependent individual
酒精中毒 alcoholism
局部人工心脏 partial artificial heart
局部用产品 topical products
聚焦超声 focused ultrasound
卡路里计算报告 Calories Count Report
开通/关闭运动神经波动 on/off motor fluctuations
抗辩协议 plea agreement
抗感染药物顾问委员会 Anti-Infective Drugs Advisory Committees
抗生素骨水泥 antibiotic bone cement
抗抑郁药 antidepressant medications
可降解医用手术缝线 dissolvable stitches
可批准函 approvable letters
可用性试验 usability testing
空运单号 Airway Bill number
口液 oral fluid
扣留令 detention order
跨领域的肿瘤项目 cross-cutting Oncology Program
快件货物操作员 express consignment operator
快速通道待遇 Fast-Track Status
拉丁美洲裔美国人健康全国联盟 National Alliance for Hispanic Health
拉丁美洲裔社区 Hispanic community
老龄局 Administration on Aging,AoA
酪蛋白 casein
勒索阴谋 extortion plot
李斯特菌 listeria
利益相关者 stakeholder
立法副专员 Associate Commissioner for Legislation
立法助理专员 Assistant Commissioner for Legislation
联邦-州响应计划 integrated federal-state response plans
联邦登记薄 Federal Register
联邦电子规章制定端口 Federal e-Rulemaking Portal
联邦调查局 Federal Bureau of Investigation,FBI
联邦风险公开规则 federal risk disclosure rules
联邦检察官 United States Attorney
联邦警察 United States Marshals
联邦警察局 U.S. Marshals Service
联邦售后使用数据 U.S. postmarketing use data
联邦宪法 United States Constitution
联邦邮政检查局 United States Postal Inspection Service[USPIS]
联邦执法局 U.S. Marshal’s Service
联合的实验室的FDA-FSIS食品紧急事件反应网络 joint FDA-FSIS Food Emergency Response Network[FERN] of laboratories
脸部消瘦 facial wasting
良好农业与管理规范 good agricultural and management practices
良好药物警戒规范和药物流行学评估》 Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
疗效相等物 therapeutic equivalents
疗养院 nursing homes
劣质的 adulterated
临床数据交换标准协会 Clinical Data Interchange Standards Consortium,CDISC
零售场所 retail establishments
流弊(转入非法渠道) diversion
流感季节 flu season
流感疫苗接种 influenza vaccination
漏报 underreport
路边摊 roadside stands
氯霉素 chloramphenicol
伦理行为标准 Standards of Ethical Conduct
伦理行为规章的补充标准 Supplemental Standards of Ethical Conduct Regulations
麻黄 ephedra
麻黄碱 ephedrine alkaloids
麻醉性的 narcotic
慢性酒精中毒 chronic alcoholism
慢性阻塞性肺病 chronic obstructive pulmonary disease,COPD
盲性审查 blinded review
没收 condemn
每月通讯 monthly newsletters
美国癌症学会 American Cancer Society
美国国家妇女健康信息中心 National Womens Health Information Center,NWHIC
美国国家老龄理事会 National Council on the Aging
美国海关和边境保护局 Customs and Border Protection [CBP]
美国护理学会 American Nurses Association[ANA]
美国护士基金会 American Nurses Foundation[ANF]
美国护士协会 American Nurses Association
美国老龄协会 American Society on Aging
美国农业部食品安全检查局 Food Safety Inspection Service,FSIS
美国清洁空气法 U.S. Clean Air Act
美国退休者协会 American Association of Retired Persons,AARP
美国药理学与实验治疗学会 American Society for Pharmacology and Experimental Therapeutics [ASPET]
美国医疗保健协会 American Healthcare Association
美国营养科学学会 American Society for Nutritional Sciences
美国造药品 U.S.-manufactured drugs
美国证券交易委员会 Securities and Exchange Commission,SEC
美国组织库协会 American Association of Tissue Banks
泌乳 lactation
免费电话号码 toll-free number
免疫规范顾问委员会 Advisory Committee on Immunization Practices
免疫受损的 immune-compromised
民事诉讼 civil lawsuit
膜衣片剂 film-coated tablet
墨西哥裔美国人 Mexican Americans
母乳喂养 breastfeeding
奶牛 dairy cattle
囊性纤维性变病 cystic fibrosis
囊肿性纤维化基金会 Cystic Fibrosis Foundation
内窥镜/腹腔镜检查装置 endoscopic/laparoscopic instruments
内皮细胞 endothelial cells
能源和商务委员会 Committee on Energy and Commerce
牛海绵状脑病 bovine spongiform encephalopathy[BSE]
牛源性材料 cattle-derived material
牛源性材料在人用食品与化妆品中的使用 Use of Materials Derived From Cattle in Human Food and Cosmetics
脓毒症 sepsis
脓肿 abscesses
农场主市场 farmers markets
诺沃克类病毒 norovirus
偶然事件反应计划 contingency response plan
帕金森氏综合症 Parkinson’s
配方 formulation
配方奶粉 powdered formulas
喷雾剂产品 aerosol products
皮肤移植 skin grafts
皮下脂肪萎缩 lipoatrophy
普通非心脏的胸膜腔镜胸外科手术 general non-cardiac thoracoscopic chest surgery
普通腹腔镜胆囊手术 general laparoscopic gall bladder surgery
谱系 pedigree
浅表性基底细胞癌 superficial basal cell carcinom,sBCC
亲密性伙伴 sexually intimate partner
禽舍 poultry houses
青年导向组织 youth- oriented organizations
轻度认知缺损 mild cognitive impairment
全国大学生体育协会 National Collegiate Athletic Association[NCAA]
全国妇女更年期认知月 National Menopause Awareness Month
全国关键性通道机会清单 National Critical Path Opportunities List
全国记者俱乐部 National Press Club
全国社会药师协会 National Community Pharmacists Association [NCPA]
全国西班牙语健康联盟 National Alliance for Hispanic Health
全国性动物识别系统 national animal identification system
全国性消费者警报 Nationwide Consumer Alert
全国药房委员会协会 National Association of Boards of Pharmacy
全局目标 overarching goal
全器官 whole organs
缺乏抵抗力的免疫系统 compromised immune systems
热带风暴 tropical storm
热量计数 Calories Count
人道主义器械豁免 Humanitarian Device Exemption,HDE
人工脊椎盘 artificial spinal disc
人类基因转移研究数据系统 Human Gene Transfer Research Data System
认知障碍 cognitive disorders
日需百分率 Percent Daily Value
日值百分数 Percent of Daily Value
肉毒碱 carnitine
肉类检查系统 meat inspection system
三边合作宪章 Trilateral Cooperation Charter
色素认证 color certification
色素添加剂 color additives
沙丁胺醇定量吸入器 albuterol metered-dose inhalers,MDIs
沙门氏菌病 salmonellosis
伤口愈合不良 impaired wound healing
商品名数据 brand-name data
商品名药 brand-name drugs
商品信贷机构 Commodity Credit Corporation
商业拓展 business outreach
商业信息片 infomercials
上市后经验 post marketing experience
上市前风险评估 Premarketing Risk Assessment
舌下传感器 Sublingual Sensor
社区热线服务电话 community helpline
申请审查工作 petition review processes
神经毒素 neurotoxin
神经性疼痛 Neuropathic Pain
审查模板行动 Review Template Initiative
肾衰竭 Renal Failure
生产配额 manufacturing quotas
生产设施 manufacturing facility
生物安全项目 biosecurity program
生物盾计划 Project BioShield
生物防卫对抗措施 biodefense countermeasures
生物制品许可证 biologics license
生紫花苜蓿芽菜 raw alfalfa sprouts
失效日期 expiration dates
时间框架 time frames
食类食品 ready-to-eat
食品GMP现代化工作组 Food GMP Modernization Working Group
食品、药品和化妆品法 Food, Drug, and Cosmetic Act
食品顾问委员会 Food Advisory Committee
食品过敏原标识和消费者保护法 Food Allergen Labeling and Consumer Protection Act
食品接触物质 food contact substances
食品添加剂安全办公室 Office of Food Additive Safety[OFAS]
食品相关危机和事故管理活动 food-associated crisis- and incident-management activities
食物过敏源 food allergens
食物过敏症 food allergies
食用蛋市场 table egg market
食源性病原体 foodborne pathogens
食源性疾病 foodborne illness
食源性疾病的诊断和管理:给内科医生和其它医疗保健专业人士的读本
Diagnosis and Management of Foodborne Illnesses: A Primer for Physicians
and Other Health Care Professionals
实质等同性 substantial equivalence
实质型结核 solid nodules
使用单位 Unit of Use
事先通告暂行最终规则 prior notice interim final rule,IFR
嗜睡 excessive sleepiness
释放率 release rate
市场独占权 exclusive marketing
视觉损伤 visual impairment
视网膜剥离 retinal detachment
视物变形 distorted vision
试验数据表格样式 Study Data Tabulation Model,SDTM
试验性应用 pilot implementation
首席项目官员 Chief Programs Officer
首席运营官 Chief Operating Officer
首席执行官 Chief Executive Officer,CEO
受监督的释放 supervised release
受限制器械 restricted devices
兽药用户收费法 Animal Drug User Fee Act
书档 bookend
数据安全和监测委员会 Data Safety and Monitoring Boards
数据安全监测委员会 data safety monitoring board
双盲对照试验 double-blind controlled studies
司法部 Department of Justice
司法部民事处 Civil Division
诉讼 complaint;prosecution
算机体层摄影术 computed tomography ,CT
随访 follow-up
糖尿病测试条 diabetic test strips
糖尿病性周围神经病变 diabetic peripheral neuropathy
陶瓷器皿 glazed ceramic vessels
特别标签 extra label
特别项目资深顾问 Senior Advisor for Special Projects
特定风险材料 specified risk materials,SRMs
特定阈值 specific thresholds
特殊健康问题办公室 Office of Special Health Issues
特异反应性再生障碍性贫血 idiosyncratic aplastic anemia
提单号 Bill of Lading
提交者 submitters
提议的规则 proposed rule
体外诊断盒 in-vitro diagnostic kits
体液渚留 fluid retention
体重控制药物临床评价指南 Guidance for the Clinical Evaluation of Weight-Control Drugs
条形码 bar codes
通常被认为安全的物质 generally recognized as safe[GRAS] substances
通告和意见 notice-and-comment
通用名的相等物 generic equivalents
通用名药 generic drug
同谋 conspirator
同意判决书 consent decree
退还政策 return policy
退伍军人医疗中心 Veterans Affairs Medical Center
外关系准局长 Associate FDA Commissioner for External Relations
外生殖器疣 external genital warts
外周神经病 peripheral neuropathy
完全回应函 complete response letters
晚期转移性前列腺癌 advanced metastatic prostate cancer
网络搜索器/数据挖掘技术 web crawler/data mining technology
威胁评估 threat assessments
微管蛋白 tubulin
危害分析与关键控制点 Hazard Analysis and Critical Control Point,HACCP
违约赔偿金 liquidated damages
胃肠穿孔 gastrointestinal perforation
胃肠道药物咨询委员会 Gastrointestinal Drugs Advisory Committee
文档管理部 Division of Dockets Management
文件编档者 filers
文身 tattooing
问卷 questionnaire
问题指南 Question Guide
污染物 contaminants
西尼罗河病毒 West Nile virus
吸血水生动物 bloodsucking aquatic animals
洗钱 launder money
系统故障情况 system downtime scenarios
先天性代谢缺陷 inborn errors of metabolism
现行化学、生产和控制 current chemistry, manufacturing and controls,CMC
现行良好生产规范 Current Good Manufacturing Practice
现行良好制造规范 current good manufacturing practice,CGMP
限制性健康声称 qualified health claims
消费者告诫 consumer tips
消费者诉讼组 Consumer Litigation Section
消费者投诉协调人 consumer complaint coordinator
消费者友好 consumer-friendly
消费者忠告 Consumer Advisory
小规模试验 pilot
小龙虾 crayfish
小母鸡 pullets
小肉牛 veal calves
小型化的心脏泵 miniaturized heart pump
小组生物制品工作组 Team Biologics Operations Group
效能 potency
斜视 strabismus
新分子实体 new molecular entity
新闻工作者午宴 Newsmaker Luncheon
新药化学办公室 Office of New Drug Chemistry
新药申请 New Drug Applications,NDAs
心搏骤停 sudden cardiac arrest
心肺复苏术 cardiopulmonary resuscitation,CPR
心肌梗死 heart attack
心律失常 cardiac arrhythmias
心跳骤停 cardiac arrest
信息单 information sheet
兴奋剂 stimulants
行为风险因子 behavioral risk factors
行业指南:关于人类细胞、组织以及细胞的和基于组织的产品的供体的合格测定
Guidance for Industry:Eligibility Determination for Donors of Human
Cells, Tissues, and Cellular and Tissue-Based Products[HCT/Ps]
行业指南:系统出错时进口食品事先通告的应急计划 Guidance for Industry:Prior Notice of Imported Food Contingency Plan for System Outages
行政程序法 Administrative Procedure Act
胸壁 chest wall
胸骨切开术 sternotomy
胸机能不全综合症 Thoracic Insufficiency Syndrome
胸廓切开术 thoracotomy
胸膜腔镜辅助的心切开术 thoracoscopically-assisted cardiotomy procedures
雄烯二酮 androstenedione
虚假或误导的声称 false or misleading claims
虚伪声明 misstatements
宣告性 declaratory
悬带 sling
选派机会 detail opportunities
选择性环氧化酶2抑制剂 Cox-2 selective
血管成形术 angioplasty
血管发生抑制剂 angiogenesis inhibitor
血管内皮生长因子 vascular endothelial growth factor,VEGF
血栓 blood clots
血型 blood group and type
循证审查 evidence-based reviews
压迫器气袖 compression device sleeves
严重急性呼吸器官综合症 Severe Acute Respiratory Syndrome,SARS
严重腋下出汗 severe underarm sweating
严重左心室衰竭 severe left ventricle failure
延释型止痛药物 extended release pain medication
延释制剂 extended-release formulation
眼内透镜 intraocular lens,IOL
眼睑痉挛 blepharospasm
药房监管人员 pharmacy regulatory officials
药品集团 drug ring
药品检查合作计划 Pharmaceutical Inspection Cooperation Scheme
药品进口工作组 Task Force on Drug Importation
药品申请绩效目标 drug application review performance goals
药品使用信息 drug regimen information
药品质量评估体系 pharmaceutical quality assessment system
药品质量委员会 Council on Pharmaceutical Quality
药物释放支架 drug-eluting stents
药效研究实施程序 Drug Efficacy Study Implementation process,DESI
药用水蛭 medicinal leeches
一线治疗药物 first-line treatment
一致性 consistency
医护人员标识 health professional labeling
医疗保健费用 healthcare costs
医疗保健机构 healthcare facilities
医疗保险处方药益处 Medicare prescription drug benefit
医疗保险改良法 Medicare improvement act
医疗器械用户收费和现代化法 Medical Device User Fee and Modernization Act (MDUFMA)
医疗社保与医疗救助服务中心 Centers for Medicare and Medicaid Services
医师用标签 physician labeling
医学成像 medical imaging
医院病床安全工作组 Hospital Bed Safety Work Group
遗传性酪氨酸血症 hereditary tyrosinemia
胰功能不全制品 pancreatic insufficiency products
胰酶 pancreatic enzyme
胰外分泌功能不全症 exocrine pancreatic insufficiency disorder
胰脏提取物 pancreatic extract
胰脂肪酶 pancrealipase
乙酰胆碱 acetylcholine
以电子格式进行规范报送──人用药申请及相关报送 Providing
Regulatory Submissions in Electronic Format--Human Pharmaceutical
Applications and Related Submissions
易感性 vulnerability
异戊酸酸血症 isovaleric acidemia
异种移植 xenotransplantation
阴道干燥 vaginal dryness
饮料粉冲泡饮料 powdered beverage
饮食补充剂 dietary supplements
饮食补充剂健康和教育法》 Dietary Supplement Health and Education Act[DSHEA]
引证程序 referral procedure
隐蔽数据 blinded data
隐形眼镜 contact lenses
英国药品与医疗保健产品监管局 Medicines and Healthcare Products Regulatory Agency, MHRA
婴儿配方 baby formula
应答性 responsiveness
影响评估 exposure assessments
永久禁令 Permanent Injunction
永久性禁令救济 permanent injunctive relief
用法说明 Directions for Use
用户收费绩效目标 user fee performance goals
用户收费弃权 user fee waivers
用药过量 overdose
用于批准的上市新药申请;完全回应函;对未批准申请的修正Applications
for Approval to Market a New Drug; Complete Response Letter; Amendments
to Unapproved Applications
用于行业和FDA工作人员的指南草案;用于减少被困事故的医院病床系统尺度指南
Draft Guidance for Industry and FDA Staff; Hospital Bed System
Dimensional Guidance to Reduce Entrapment
优先审查 Priority Review
有效的专卖权声称 valid exclusivity claims
有效性 validity
有罪抗辩 guilty pleas
于在传统的人用食品和人用膳食补充剂标识中的限制性健康声称的暂行程序
Interim Procedures for Qualified Health Claims in the Labeling of
Conventional Human Food and Human Dietary Supplements
预后 outcome
预算授权 budget authority
预先的法院指令 preliminary injunction
预先的禁令 preliminary injunction order
预先批准 preapproval
元数据 metadata
原发性腋窝多汗症 primary axillary hyperhidrosis
原料药 bulk drug
员工指南手册 Staff Manual Guide
运动障碍 dyskinesias
孕激素 progestin
孕酮 progestin
再水合剂 rehydrating agents
暂扣 detain
责任通报 mandatory reporting
粘性衬垫 adhesive pads
镇定剂 tranquilizers
镇静剂 sedatives
镇痛剂 pain relievers
征兆 sign
政策代理副专员 Acting Deputy Commissioner for Policy
政策协调委员会 Policy Coordinating Council
*层面的生物监视行动 government-wide Bio-Surveillance Initiative
*伦理办公室 Office of Government Ethics
知情决定 informed decision
直肠癌 colorectal cancer
植入型透镜 implanted lens
植物性药材 botanicals
执行级别 executive level
执行决定 enforcement discretion
执业医师 medical practitioner
指定供体 directed donor
指令 directives
指令性 injunctive
止汗剂 antiperspirants
纸板陈列盒 display box
质量控制规程 quality control procedures
质量体系规章 Quality System regulation
治疗不足 undertreated
治疗用生物制品 therapeutic biologics
中风 stroke
中链脂酰辅酶A脱氢酶缺乏 medium chain Acyl-CoA dehydrogenase deficiency,MCAD
中心间协调小组 inter-center coordinating group
肿瘤学药品办公室 Office of Oncology Drug Products,OPD
重度至极度 severe-to-profound
重新包装商 repackager
重新补水 rehydration
重组DNA生物技术 recombinant DNA biotechnology
重组治疗性蛋白 recombinant therapeutic proteins
众议院*改革委员会 House Government Reform Committee Chairman
州农业部全国协会 National Association of State Departments of Agriculture,NASDA
皱眉纹 frown lines
猪胰岛素锌悬浮液产品 porcine insulin zinc suspension product
主张 allegations
助理首席检察官 Assistant Attorney General
助听器 hearing aids
注册护士 registered nurse,RN
注射型填充剂 injectable filler
注射用透明质酸酶 hyaluronidase for injection
专家审查刊物 peer-reviewed journal
专题研讨会 workshops
专业协会 professional associations
专职员工 full-time staff
转移 diversion
转运者 transmitters
装饰性隐形眼镜 decorative contact lenses
桌面演练 tabletop exercises
咨询/通知工作 consultation/notification processes
子宫颈癌 cervical cancer
子宫内膜癌 endometrial cancer
子宫切除 hysterectomy
自动体外除颤器 Automatic External Defibrillator
自然晶状体 natural lens
自杀 suicidality
综合方法 integrated approach
总统AIDS救济紧急计划 Presidents Emergency Plan for AIDS Relief
组合包装 co-packaged
组织安全系统 Tissue Safety System
最低限度处理的骨髓 minimally-manipulated bone marrow
最新 state-of-the-art
左旋多巴 L-dopa
槭糖尿病 maple syrup urine disease,MSUD
飓风 hurricane
酰基肉毒碱 acylcarnitines
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