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Acronyms
<%end if%> Drug discovery & development Site Map Regulatory Affairs Informatics Site map Technologies Site map Biology & Chemistry Site map Finding guide to terms in these glossaries Site Map This is a work in progress. 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 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 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 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 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 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
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