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CLNR 515 Acronyms week2
CLNR 515 Acronyms week2
47
Science
Graduate
09/01/2008

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Term
CLIA
Definition
Clinical Laboratories Improvement Amendments of 1988
Term
CMC
Definition
Chemistry and Manufacturing Controls
Term
CMO
Definition
Contract Management Organization
Term
CMS
Definition
Centers for Medicare and Medicaid Services Admin for SCHIP, HIPAA, & CLIA.
Term
COE
Definition
Code of Ethics or Certificate of Exportability
Term
CPSC
Definition
Consumer Products Safety Commission
Term
CRC
Definition
Clinical Research Coordinator
Term
CRF
Definition
Case Report Form
Term
CRO
Definition
Contract Research Organization
Term
CS
Definition
Clinically Significant
Term
CSO
Definition
Consumer Safety Officer - usually contract person at FDA. Also known as Project Manager
Term
CSR
Definition
Clinical Study Report
Term
CT
Definition
Clinical Trial
Term
CTC
Definition
Clinical Trial Certificate
Term
CTD
Definition
Common Technical Document
Term
CVM
Definition
Center for Veterinary Medicine
Term
DDMAC
Definition
Division of Drug Marketing, Advertising and Commmunications (CDER)
Term
DEA
Definition
Drug Enforcement Administration
Term
DHF
Definition
Design History File- Describes design of a finished device
Term
DHR
Definition
Design History Record - Contains the production history of a device
Term
DMF
Definition
Drug Master File - Submission to FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the processing, packaging, and storing one or more human drugs.
Term
DMR
Definition
Device Master Record
Term
DOs
Definition
District Offices
Term
DQRS
Definition
Drug Quality Reporting System
Term
DSMB
Definition
Data and Safety Monitoring Board
Term
DSMICA
Definition
Division of Small Manufacturers, International and Consumer Assistance (CDRH)
Term
DTC
Definition
Direct-to-Consumer (advertising)
Term
EIA
Definition
Environmental Impact Assessment
Term
EIR
Definition
Establishment Inspection Report
Term
EPL
Definition
Effective Patent Life
Term
EUP
Definition
Experimental Use Permit
Term
FAR
Definition
Field Alert Report
Term
FD&C Act
Definition
Food, Drug and Cosmetics Act of 1938
Term
FDA
Definition
Food and Drug Administration
Term
FDAMA
Definition
Food and Drug Administration Modernization Act of 1997
Term
FOIA
Definition
Freedom of Information Act of 1966
Term
FPLA
Definition
Fair Packaging and Labeling Act
Term
FR
Definition
Federal Register
Term
FTC
Definition
Federal Trade Commission
Term
FY
Definition
Fiscal Year (FDA = Oct. - Sept)
Term
GATT
Definition
General Agreement of Tariffs and Trade
Term
GCP
Definition
Good Clinical Practice
Term
GGP
Definition
Good Guidance Practice
Term
GHTF
Definition
Global Harmonization Task Force
Term
GLP
Definition
Good Laboratory Practices
Term
GMP
Definition
Good Manufacturing Practices
Term
GRAS(E)
Definition
Generally Recognized as Safe (and Effective)
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