Acronyms+&+Abbreviations

=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 ||
 * ATP || Advance Therapy Product ||

B

 * BLA || Biologic License Application ||
 * BRMS || Biologics Regulatory Management System ||

C
for more information, see Some CMS Links and Further Information ||
 * CAPA || Corrective And Preventative Actions ||
 * CBE || Changes Being Effected
 * [|CFR 601.12] (Biologics)
 * [|CFR 514.8] (CVM)
 * [|CFR 314.70] (Drugs) ||
 * 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]
 * 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
(International Organization for Standardization) ||
 * 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
 * ITS || Implementable Technology Specification ||
 * IUPAC || International Union of Pure and Applied Chemistry ||

J

 * JAD || Joint Application Development ||

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 ||
 * 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 ||

W

 * WHO || World Health Organisation ||

X

 * XML || eXtensible Markup Language ||
 * XSL || eXtensible Stylesheet Language ||