Acronyms & Abbreviations


Term
Definition, Expansion, Example

A

ADME
Absorption, Distribution, Metabolism and Excretion


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

B

BLA
Biologic License Application
BRMS
Biologics Regulatory Management System

C

CAPA
Corrective And Preventative Actions
CBE
Changes Being Effected
for more information, see
CBER
Center for Biologics Evaluation and Research
CBP
[US] Customs and Border Protection
CDA
Clinical Document Architecture
CDER
Center for Drug Evaluation and Research
CDMS
Clinical Data Management Systems
CDRH
Center for Devices and Radiological Health
CDS
Clinical Decision Support
CEN
European Committee for Standardization
CFR
Code of Federal Regulations
CIC
Clinical Interoperability Council
CHPA
Consumer Healthcare Products Association
CMS
Centers for Medicare and Medicaid Services
Some CMS Links and Further Information
CoL
Content of Labeling
CP
Centralised Procedure (EU)
CHMP
Committee for Medicinal Products for Human use
CPM
Common Product Model
CPOE
Computerized Provider Order Entry
CRO
Contract Research Organization
CTD
Common Technical Document
CTMS
Clinical Trial Management Software
CTRR
Clinical Trials Registration and Results
CTTI
Clinical Trials Transformation Initiative
CVM
Center for Veterinary Medicine


D

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


E

eCTD
electronic Common Technical Document (CTD)
EDC
Electronic Data Capture
EDR
Electronic Document Room
eDRLS
electronic Drug Registration and Listing System
EHR
Electronic Heath Record
ELIPS
Electronic Labeling Information Processing System
ELIS
Electronic Laboratory Information System
EMA
European Medicines Agency
EMEA
now the EMA
EPAR
European Public Assessment Reports
ER
Establishment Registration
ERF
Event Report Form
ESG
Electronic Submission Gateway
EUTCT
European Union Telematics Controlled Terms
EUDRA
European Union Drug Regulatory Authorities

F

FDA
Food and Drug Administration
FD&C
Federal Food, Drug and Cosmetic Act
FEI
FDA Establishment Identifier
FPI
Full Prescribing Information
FPL
Final Printed Label(ing)
FTC
Federal Trade Commission
FURLS
FDA’s 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
United States Department of Health and Human Services
HL7
Health Level Seven
HIBCC
Health Industry Business Communications Council
HIPAA
Health Insurance Portability and Accountability Act

I

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

J

JAD
Joint Application Development

K



L

LCM
Life Cycle Management
LCR
Labeler Code Requests
LMI
Labeler and Manufacturing Information
LOINC
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
New Animal Drug Application
NBE
New Biological Entity
NCA
National Competent Authorities
NCE
New Chemical Entity
NCI
National Cancer Institute
NCIt
National Cancer Institute Thesaurus
NDA
New Drug Application
NDC
National Drug Code
NF
National Formulary
NHS
(UK) National Health Services
NLM
National Library of Medicine
NME
New Molecular Entity
NHRIC
National Health Related Items Code

O

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


OTC
Over-the-Counter

P

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

Q

QRD
Quality Review of Documents

R

R3
SPL Schema Release 3
R4
SPL Schema Release 4
RCRIM
Regulated Clinical Research Information Management
RDM
Reference Data Model
REMS
Risk Evaluation and Mitigation Strategies
RLD
Reference Listed Drug
RMIM
Refined Message Information Model
RMP
Risk Management Plan
RPS
Regulated Product Submssion

S

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

T

TE
Therapeutic Equivalence

U

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

V



W

WHO
World Health Organisation

X

XML
eXtensible Markup Language
XSL
eXtensible Stylesheet Language

Y




Z