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Definition
| Hazard Analysis and Critical Control Point |
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| Humanitarian Device Exemption |
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| Health and Human Services - US Govmt's principal health agency that oversees numerous divisions, including FDA, NIH, CDC, and AHRQ |
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| Health Insurance Portability and Accountability Act (1996) |
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| Health Maintenance Organization |
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| International Conference on Harmonization |
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| Investigational Device Exemption |
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Definition
| Independent Data Safety Monitoring Board |
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Term
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Definition
| Investigational New Drug - must be submitted to FDA 30 days before initiating clinical testing for a drug or biologic product. |
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| International Nonproprietary Names - identify pharmaceutical substances (aka generic name) |
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| Institute of Medicine or Investigations Operations Manual |
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| Institutional Review Board |
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| International Organization for Standardization |
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| 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 |
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Definition
| Manual of Policies and Procedures |
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| 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 |
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| Medical Dictionary for Regulatory Affairs |
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| Memoranda of Understanding - agreements between regulatory authorities that allow nutual recognition of inspections |
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| 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 |
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Definition
| Mutual Recognition Agreement or Medical Research Associate |
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| Notice of Adverse Findings |
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| North American Free Trade Agreement |
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| No Action Indicated - indicated on FDA form 483 following an inspection |
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National Academy of Sciences
New Active Substance |
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| Not Clinically Significant |
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Definition
| National Center for Toxicological Research (FDA) |
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