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CLNR 515 Acronyms week 3
CLNR 515 Acronyms week 3
33
Medical
Graduate
09/07/2008

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Cards

Term
HACCP
Definition
Hazard Analysis and Critical Control Point
Term
HDE
Definition
Humanitarian Device Exemption
Term
HHS
Definition
Health and Human Services - US Govmt's principal health agency that oversees numerous divisions, including FDA, NIH, CDC, and AHRQ
Term
HIPAA
Definition
Health Insurance Portability and Accountability Act (1996)
Term
HMO
Definition
Health Maintenance Organization
Term
HPK
Definition
Human Pharmacokinetic
Term
HUD
Definition
Humanitarian Use Device
Term
IB
Definition
Investigator's Brochure
Term
ICH
Definition
International Conference on Harmonization
Term
IDE
Definition
Investigational Device Exemption
Term
IDSMB
Definition
Independent Data Safety Monitoring Board
Term
IND
Definition
Investigational New Drug - must be submitted to FDA 30 days before initiating clinical testing for a drug or biologic product.
Term
INN
Definition
International Nonproprietary Names - identify pharmaceutical substances (aka generic name)
Term
IOM
Definition
Institute of Medicine or Investigations Operations Manual
Term
IRB
Definition
Institutional Review Board
Term
ISO
Definition
International Organization for Standardization
Term
IVD
Definition
In Vitro Diagnostic
Term
LOA
Definition
Letter of Agreement or Letter of Authorization - a letter from the holder of a Drug Master File (DMF) authorizing a company to reference a DMF
Term
MAPP
Definition
Manual of Policies and Procedures
Term
MDA
Definition
Medical Device Amendments (1976) - established 3 regulatory classes (I, II, III) for medical devices. Based on the degree of control necessary to assurethe various types of devices are safe and effective
Term
MDR
Definition
Medical Device Reporting
Term
MedDRA
Definition
Medical Dictionary for Regulatory Affairs
Term
MOH
Definition
Ministry of Health
Term
MOU
Definition
Memoranda of Understanding - agreements between regulatory authorities that allow nutual recognition of inspections
Term
MQSA
Definition
Mammography Quality Standards Act of 1992 - ensures all women have access to quality mammography for the detection of breast cancer in its earliest, most treatable stages
Term
MRA
Definition
Mutual Recognition Agreement or Medical Research Associate
Term
NAF
Definition
Notice of Adverse Findings
Term
NAFTA
Definition
North American Free Trade Agreement
Term
NAI
Definition
No Action Indicated - indicated on FDA form 483 following an inspection
Term
NAS
Definition
National Academy of Sciences
New Active Substance
Term
NCE
Definition
New Chemical Entity
Term
NCS
Definition
Not Clinically Significant
Term
NCTR
Definition
National Center for Toxicological Research (FDA)
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