ANDA简化新药申请abbreviated new drug applications         

API原料药active pharmaceutical ingredient

AQSIQ国家质检总局Administration of Quality Supervision, Inspection and Quarantine

CBER生物制品评审与研究中心Center for Biologics Evaluation and Research 

CDER药品审评与研究中心Center for Drug Evaluation and Research 　　 CDER's MAPP 5240.3

CDRH器械和辐射健康中心Center for Devices and Radiological Health 

CFDA中国国家食品药品监督管理局

cGMP当前GMP、国际GMP规范  (c=current)     

CMC  化学、制造、控制

DMF药物主文件drug master file

DUNS  Data Universal Numbering System 

eCTD电子版通用技术文件Electronic Common Technical Document 

FDASIA   Food and Drug Administration Safety and Innovation Act 

FDF成品药、药品剂型完成 finished dosage form

FEI工厂注册识别号Facility Establishment Identifier 

GDUFA仿制药企业付费法/仿制药用户收费法案Generic Drug User Fee Amendment/Act

GMP   Good Manufacturing Practice

GPhA美国仿制药协会@华盛顿

HHS健康和公众服务部Health and Human Services

IID非活性成分数据库inactive ingredient database

ICH国际协调会议International Conference on Harmonisation

IR信息要求information request

NIH美国国立卫生研究院

OBP生物技术产品办公室

OC合规办公室Office of Compliance  //局长办公室/专员Commissioner办公室

OCC法律事务办公室Office of Chief Counsel

OGD仿制药办公室Office of Generic Drug

OGROP全球业务和政策监管办公室Office of Global Regulatory Operations & Policy

OIP国际项目办公室Office of International Programs

OND  新药办公室Office of New Drug

ONDQA新药质量评估办公室Office of New Drug Quality Assessment 

OPQ  药品质量办公室Office of Pharmaceutical Quality

ORA监管事务办公室

OSE监管和流行病办公室Office of Surveillance and Epidemiology

OSP战略项目办公室

OTS转化科学办公室

PAG项目并进小组Program Alignment