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Biopharmaceutical Acronyms
Evolving Terminology for Emerging Technologies
Comments? Questions? Revisions?  Mary Chitty
Last revised October 17, 2014
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BioPax:  Biological Pathways Exchange.  A collaborative effort to create a data exchange format for biological pathway data. 

BISTI:  Biomedical Information Science & Technology Initiative 

Bristol Myers Squibb  

CBER: Center for Biologics Evaluation and Research FDA

CDER: Center for Drug Evaluation and Research, FDA

CDRH: Center for Devices and Radiological Health, FDA

CFR: Code of Federal Regulations.  Title 21 covers Food and Drugs

CFSAN: Center for Food Safety and Applied Nutrition

cGMP: current Good Manufacturing Practice

CLIA: Clinical Laboratory Improvement Amendments

CRA: Clinical Research Associate

CRC Clinical Research Coordinator

Clinical Research Investigator

EBI: European Bioinformatics Institute, Hinxton, Cambridge, UK. An EMBL outstation.

eCTD: Electronic Common Technical Document 

EMA: European Medicines Agency was EMEA: European Medicines Evaluation Agency   

EFPIA: European Federation of Pharmaceutical Industries and Associations

FDA Food and Drug Administration

FDAMA: Food and Drug Modernization Act of 1997

GCP: Good Clinical Practice

GLP: Good Laboratory Practice

GMP: Good Manufacturing Practice

GSK: GlaxoSmithKline 

HCV: Hepatitis C

HIPAA: Health Insurance Portability and Accounting Act, Health & Human Services, US

ICH:  International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

IDE: Investigational Device Exemption

nvestigational New Drug Application

IRB: Institutional Review Board

IVDMIA: in Vitro Diagnostic Multivariate Index Assays

J&J, jnj: Johnson & Johnson Many companies come under the Johnson & Johnson name. 

KOLs: Key Opinion Leaders

MDUFA: Medical Device User Fee and Modernization Act

MedDRA: Medical Dictionary for Regulatory Activities

: Medicines and Healthcare products Regulatory Agency, UK

MIAME: Minimum Information About a Microarray Experiment 

NCE: New Chemical Entity

NCTR: National Center for Toxicological Research, FDA

NDA: New Drug Application

NME: New Molecular Entity

OTC: Over the Counter drugs

OWG: Ontology Working Group 

PDUFA: Prescription Drug User Fee Act 1992

PANDRH: Pan American Network on Drug Regulatory Harmonization

PDMA:  Pharmaceuticals and Medical Devices Agency, Japan
PhRMA: Pharmaceutical Research and Manufacturers of America

PMA: PreMarket Approval

PSUR: Periodic Safety Update Report

REMS: Risk Evaluation and Mitigation Strategy

SADC: South African Development Community, and one of the Regional Harmonisation Initiatives (RHIs)

WHO: World Health Organization, one of the ICH Observers

WSMI: World Self-Medication Industry, and one of the ICH Interested Parties

FDA Acronyms & Abbreviations 

Glossary, Association of British Healthcare Industries Ltd. , 2007  
ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Glossary 

IUPAC, Abbreviations and acronyms used in the Toxicology Literature, IUPAC Glossary of Toxicology, 2007 
IUPAC, Abbreviations and acronyms of names of International Bodies

Alpha glossary index
How to look for other unfamiliar  terms

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