Acronyms & Abbreviations

Term Definition, Expansion, Example

A
ADME AdvaMed ADUFA AERS AGDUFA AHI ANADA ANDA ANSI API ATC ATP Absorption, Distribution, Metabolism and Excretion Advanced Medical Technology Association Animal Drug User Fee Act Adverse Events Reporting System Animal Generic Drug User Fee Act Animal Health Institute Abbreviated New Animal Drug Application Abbreviated New Drug Application American National Standards Institute Active Pharmaceutical Ingredient Anatomical Therapeutic Chemical Advance Therapy Product

B
BLA Biologic License Application BRMS Biologics Regulatory Management System

C
CAPA Corrective And Preventative Actions Changes Being Effected for more information, see CFR 601.12 (Biologics) CBE CFR 514.8 (CVM) CFR 314.70 (Drugs) CBER Center for Biologics Evaluation and Research CBP [US] Customs and Border Protection CDA Clinical Document Architecture

CDER CDMS CDRH CDS CEN CFR CIC CHPA CMS CoL CP CHMP CPM CPOE CRO CTD CTMS CTRR CTTI CVM

Center for Drug Evaluation and Research Clinical Data Management Systems Center for Devices and Radiological Health Clinical Decision Support European Committee for Standardization Code of Federal Regulations Clinical Interoperability Council Consumer Healthcare Products Association Centers for Medicare and Medicaid Services Some CMS Links and Further Information Content of Labeling Centralised Procedure (EU) Committee for Medicinal Products for Human use Common Product Model Computerized Provider Order Entry Contract Research Organization Common Technical Document Clinical Trial Management Software Clinical Trials Registration and Results Clinical Trials Transformation Initiative Center for Veterinary Medicine

D
DCR DDI DDMAC DES DFARS DFAS DIOP DL DLD DMR DRLM DSMICA DTD DUNS DWPE Document Change Request Department of Drug Information (Part of CDER) Division of Drug Marketing, Advertising and Communications Data Exchange Standard Drug Firm Annual Registration Status Defense Finance and Accounting Services Division of Import Operations and Policy Drug Listing Drug Listing Data Digital Medical References Device Registration and Listing Module Division of Small Manufacturers, International and Consumer Assistance Document Type Definition Dun and Bradstreet Unique Numbering System Detained without Physical Examination

E
eCTD electronic Common Technical Document (CTD)

EDC EDR eDRLS EHR ELIPS ELIS EMA EMEA EPAR ER ERF ESG EUTCT EUDRA

Electronic Data Capture Electronic Document Room

electronic Drug Registration and Listing System

Electronic Heath Record Electronic Labeling Information Processing System Electronic Laboratory Information System European Medicines Agency now the EMA European Public Assessment Reports Establishment Registration Event Report Form Electronic Submission Gateway European Union Telematics Controlled Terms

European Union Drug Regulatory Authorities

F
FDA FD&C FEI FPI FPL FTC FURLS Food and Drug Administration Federal Food, Drug and Cosmetic Act FDA Establishment Identifier Full Prescribing Information Final Printed Label(ing) Federal Trade Commission FDAs Unified Registration and Listing System

G
GADA Generic Animal Drug Alliance GHTF Global Harmonization Task Force GMDN Global Medical Device Nomenclature GPhA Generic Pharmaceuticals Association GS1 Global Standards GTIN Global Trade Item Numbers GUID Globally Unique IDentifier:

H
HHS HL7 HIBCC HIPAA United States Department of Health and Human Services Health Level Seven Health Industry Business Communications Council Health Insurance Portability and Accountability Act

I
IDMP IG IMP IMPD IND INN ISBT ISMP Identification of Medicinal Products Implementation Guide Investigational Medicinal Product Investigational Medicinal Product Dossier Investigational New Drug International Nonproprietary Name International Society of Blood Transfusion Institute for Safe Medical Practices International Standards Organisation ISO (International Organization for Standardization) ITS Implementable Technology Specification IUPAC International Union of Pure and Applied Chemistry

J
JAD Joint Application Development

K L
LCM LCR LMI LOINC Life Cycle Management Labeler Code Requests Labeler and Manufacturing Information Logical Observation Identifiers Names and Codes

M
MHRA (UK) Medicines and Healthcare products Regulatory Agency
MPID Medicinal Product ID MDUFMA Medical Device User Fee and Modernization Act

N
NADA NBE NCA NCE NCI NCIt NDA New Animal Drug Application New Biological Entity National Competent Authorities New Chemical Entity National Cancer Institute National Cancer Institute Thesaurus New Drug Application

NDC NF NHS NLM NME NHRIC

National Drug Code National Formulary (UK) National Health Services National Library of Medicine New Molecular Entity National Health Related Items Code

O
OC OGD OID OIG OMB OND Office of the Commissioner (FDA) Office of Generic Drugs Object Identifier Definition Office of the Inspector General Office of Management and Budget Office of New Drugs

OTC Over-the-Counter

P
PAS PDP PDUFA PhRMA PIM PK PLD PLR PMA PPI PRS PVL Prior Approval Submission (from submission process chart) Principal Display Panel Prescription Drug User Fee Act Pharmaceutical Research and Manufacturers Association Product Information Model Pharmokinetics Private Label Distributor Physician's Labeling Rule Pre-Market Approval Patient Prescribing Information Protocol Registration System Pragmatic Validator Lite

Q
QRD Quality Review of Documents

R
R3 R4 RCRIM RDM REMS RLD RMIM SPL Schema Release 3 SPL Schema Release 4 Regulated Clinical Research Information Management Reference Data Model Risk Evaluation and Mitigation Strategies Reference Listed Drug

Refined Message Information Model

RMP RPS

Risk Management Plan Regulated Product Submssion

S
SmPC sNDA SPL SRS Summary of Product Characteristics Supplemental New Drug Application (NDA) Structured Product Labeling Substance Registration System

T
TE Therapeutic Equivalence

U
UCUM UDI UNII UPC URI USAN USP Unified Codes for Units of Measure Unique Device Identification Unique Ingredient Identifier Universal Product Code Uniform Resource Identifier US Adopted Names (Council) United States Pharmacopeia

V W
WHO World Health Organisation

X
XML eXtensible Markup Language XSL eXtensible Stylesheet Language