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Biopharmaceutical Acronyms
Evolving Terminology for Emerging Technologies
Comments? Questions? Revisions?  Mary Chitty  mchitty@healthtech.com
Last revised March 23, 2012
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BioPax:  Biological Pathways Exchange.  A collaborative effort to create a data exchange format for biological pathway data. http://www.biopax.org/ 

BISTI:  Biomedical Information Science & Technology Initiative http://www.bisti.nih.gov/bistic2.cfm 

BMS: 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

CRI: Clinical Research Investigator

EBI: European Bioinformatics Institute, Hinxton, Cambridge, UK. An EMBL outstation.  http://www.ebi.ac.uk/

eCTD: Electronic Common Technical Document http://www.fda.gov/cder/regulatory/ersr/ectd.htm 

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 http://www.gsk.com/ 

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

IND: Investigational New Drug Application

IRB: Institutional Review Board

IVDMIA: in Vitro Diagnostic Multivariate Index Assays

J&J, jnj: Johnson & Johnson http://www.jnj.com/home.htm  Many companies come under the Johnson & Johnson name. http://www.jnj.com/our_company/family/index.htm

KOLs: Key Opinion Leaders

MDUFA: Medical Device User Fee and Modernization Act

MedDRA: Medical Dictionary for Regulatory Activities

MHRA: Medicines and Healthcare products Regulatory Agency, UK

MIAME: Minimum Information About a Microarray Experiment http://www.mged.org/Workgroups/MIAME/miame.html 

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 http://mged.sourceforge.net/ontologies/index.php 

PDUFA: Prescription Drug User Fee Act 1992

PANDRH: Pan American Network on Drug Regulatory Harmonization

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)

Bibliography
FDA Acronyms & Abbreviations, 2010 http://www.fda.gov/aboutfda/fdaacronymsabbreviations/default.htm 
Glossary, Association of British Healthcare Industries Ltd. , 2007  http://www.abhi.org.uk/glossary/default.aspx  
ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Glossary http://www.ich.org/glossary.html 
IUPAC, Abbreviations and acronyms used in the Toxicology Literature, IUPAC Glossary of Toxicology, 2007  http://sis.nlm.nih.gov/enviro/iupacglossary/annex1.html 
IUPAC, Abbreviations and acronyms of names of International Bodies http://sis.nlm.nih.gov/enviro/iupacglossary/annex2.html  

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