Abbreviations & Acronyms:

BLA - biologics license application
BPM - business process management

CAPA - corrective and preventive action
CBT - computer based training
CFR - Code of Federal Regulations
cGMP - current good manufacturing practice
CIOMS - Council for International Organizations of Medical Sciences
CME - continuing medical education
CQA - clinical quality assurance
CRA - clinical research associate
CRF - case report form
CRO - contract research organization
CTMS - clinical trial management system
CTR - clinical trial registry

DDMAC - Division of Drug Marketing, Advertising and Communications
DOJ - Department of Justice
DTC - direct to consumer
DTP - direct to patient

eCTD - electronic common technical document
ED - erectile dysfunction
EMA or EMEA - European Medicines Agency
EU - European Union

FCPA - Foreign Corrupt Practices Act

FDA - Food and Drug Administration
FDA3 - Food and Drug Administration Amendments Act
FDAAA - Food and Drug Administration Amendments Act
FOB – follow on biologic

GCP - good clinical practice
GLP - good laboratory practice
GMP - good manufacturing practice
GRP - good reprint practices

GxP - good x practice (any of the good practices)

HCP - health care professional
HME - home medical equipment
HRx - HR-human resources; Rx-prescription

ICH - International Conference on Harmonization
IND - investigational new drug
IRB - institutional review board
IVRS - interactive voice response system
IWRS - interactive web response system

KOL - key opinion leader

MDUFA - Medical Device User Fee Amendments
MHRA - Medicines and Healthcare Product Regulatory Agency (UK)
MSL - medical science liaison

NDA - new drug application

OIG - Office of Inspector General
OTC - over the counter

PAI - pre-approval inspection
PAP - patient assistance program
PMA - pre-market approval
PMDA - Pharmaceutical and Medical Devices Agency (Japan)
POC – point of care

QA - quality assurance

RFP - request for proposal
RNAi - ribonucleic acid interference
Rx - prescription

SOP - standard operating procedure
SOX - Sarbanes-Oxley
SPL - structured product labeling

 
WOM - word of mouth