Term
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Definition
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Term
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Definition
| lnvestigational New Drug Application |
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Term
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Definition
| Statement of Investigator |
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Term
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Definition
| Certification: Financial Interest and Arrangements of Clinical Investigators |
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Term
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Definition
| Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use |
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Term
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Definition
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Term
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Definition
| lnspectional Observations |
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Term
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Definition
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Term
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Definition
| Premarket Notification Submission |
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Term
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Definition
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Term
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Definition
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Term
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Definition
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Term
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Definition
| Adverse Events Reporting System |
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Term
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Definition
| Application Integrity Policy |
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Term
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Definition
| A = Attributable; L = Legible; C = Contemporaneous; O = Original, A = Accurate |
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Term
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Definition
| Abbreviated New Drug Application |
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Term
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Definition
| Advanced Notice of Proposed Rulemaking |
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Term
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Definition
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Term
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Definition
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Term
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Definition
| Bioresearch Monitoring (FDA) |
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Term
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Definition
| Biologics License Application |
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Term
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Definition
| Basic Physiological Research (Devices) |
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Term
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Definition
| Cancer Adverse Event Reporting System |
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Term
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Definition
| Corrective and Preventive Action |
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Term
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Definition
| (FDA) Center for Biologics Evaluation and Research |
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Term
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Definition
| Clinical Data Acquisition Standards Harmonization |
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Term
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Definition
| (FDA) Center for Drug Evaluation and Research |
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Term
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Definition
| (FDA) Center for Devices and Radiological Health |
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Term
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Definition
| Code of Federal Regulations (U.S.) |
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Term
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Definition
| (FDA) Center for Food Safety and Applied Nutrition |
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Term
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Definition
| Current Good Clinical Practices |
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Term
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Definition
| Current Good Manufacturing Practices |
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Term
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Definition
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Term
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Definition
| Any experiment or research study in which a drug or treatment is given to one or more human subjects to determine the safety and / or effectiveness of the drug or treatment |
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Term
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Definition
| Compliance Program Guidance Manual |
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Term
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Definition
| Clinical Research Associate (may be with sponsor or site) |
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Term
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Definition
| Clinical Research Coordinator |
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Term
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Definition
| Case Report Form / Case Record Form |
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Term
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Definition
| Contract Research Organization |
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Term
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Definition
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Term
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Definition
| (FDA) Consumer Safety Officer |
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Term
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Definition
| Clinical Trials Management System |
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Term
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Definition
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Term
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Definition
| Center for Veterinary Medicine |
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Term
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Definition
| Division of Bioresearch Monitoring (CDRH) |
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Term
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Definition
| Division of Drug Marketing, Advertising and Communication |
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Term
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Definition
| Department of Health and Human Services |
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Term
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Definition
| Section of TPD regulations relating to clinical Trials |
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Term
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Definition
| Define, Measure, Analyze, lmprove, Control (Six Sigma Project Management) |
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Term
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Definition
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Term
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Definition
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Term
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Definition
| Division of Scientific Investigations (CDER) |
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Term
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Definition
| Data Safety Monitoring Board |
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Term
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Definition
| Data Safety Monitoring Committee |
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Term
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Definition
| Division of Small Manufacturers, international and Consumer Assistance CDRH |
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Term
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Definition
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Term
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Definition
| (FDA) Establishment Inspection Report |
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Term
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Definition
| (FDA) Establishment Inspection |
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Term
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Definition
| European Medicines Evaluation Agency (European Union) |
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Term
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Definition
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Term
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Definition
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Term
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Definition
| Federal Food, Drug, and Cosmetic Act (the Act) |
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Term
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Definition
| Food and Drug Administration |
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Term
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Definition
| Food and Drug Administration Amendment Acts of 2007 |
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Term
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Definition
| Food and Drug Administration Modernization Act (1997) |
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Term
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Definition
| Freedom of Information Act |
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Term
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Definition
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Term
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Definition
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Term
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Definition
| Fiscal Year (October 1 - September 30) |
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Term
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Definition
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Term
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Definition
| Good Clinical Practices Program (in Office of the FDA Commissioner) |
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Term
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Definition
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Term
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Definition
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Term
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Definition
| Good Manufacturing Practice (see QSR below) |
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Term
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Definition
| Humanitarian Device Exemption |
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Term
|
Definition
| Routing code for mail to the Office of the Commissioner of the FDA |
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Term
|
Definition
| Routing code for mail to CDER |
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Term
|
Definition
| Routing code for mail to CBER |
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Term
|
Definition
| Routing code for mail to CFSAN |
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Term
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Definition
| Routing code for mail to CVM |
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Term
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Definition
| Routing code for mail to CDRH |
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Term
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Definition
| Health Insurance Portability and Accountability Act |
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Term
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Definition
| Health Information Exchange |
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Term
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Definition
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Term
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Definition
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Term
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Definition
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Term
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Definition
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Term
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Definition
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Term
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Definition
| informed Consent Document |
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Term
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Definition
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Term
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Definition
| International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) |
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Term
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Definition
| International Committee of Medical Journal Editors |
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Term
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Definition
| lnvestigational Drug Brochure / Investigator Brochure |
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Term
|
Definition
| lnvestigational Device Exemption |
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Term
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Definition
| Independent Ethics Committee |
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Term
|
Definition
| (Office of the) Inspector General |
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Term
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Definition
| lnvestigational New Animal Drug |
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Term
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Definition
| lnvestigational New Drug (Application) |
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Term
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Definition
| institutional Review Board |
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Term
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Definition
| Institutional Review Committee |
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Term
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Definition
| International Organization for Standardization |
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Term
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Definition
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Term
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Definition
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Term
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Definition
| Informed Consent / Informed Consent Form / informed Consent Document |
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Term
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Definition
| Institutional Review Committee |
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Term
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Definition
| Medical Device Report (part of MedWatch) |
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Term
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Definition
| Medical Device User Fee and Modernization Act (2002) |
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Term
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Definition
| Medical Dictionary for Regulatory Activities |
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Term
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Definition
| No Action Indicated (FDA inspection classification) |
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Term
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Definition
| National Cancer Institute |
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Term
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Definition
| Not Clinically Significant |
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Term
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Definition
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Term
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Definition
| New England Journal of Medicine |
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Term
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Definition
| Notice of Initiation of Disqualification Proceeding and Opportunity to Explain |
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Term
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Definition
| National Institutes of Health, Health and Human Services |
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Term
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Definition
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Term
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Definition
| Notice of Opportunity for Hearing |
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Term
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Definition
| Non Significant Risk (Devices) |
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Term
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Definition
| Official Action Indicated (FDA inspection classification) |
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Term
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Definition
| Office of Compliance or Office of the Commissioner |
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Term
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Definition
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Term
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Definition
| Office of Criminal Investigations |
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Term
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Definition
| Office of Device Evaluation |
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Term
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Definition
| Official Establishment inventory |
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Term
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Definition
| Office of General Counsel |
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Term
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Definition
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Term
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Definition
| Office for Human Research Protections (Health and Human Services) |
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Term
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Definition
| Office of In Vitro Diagnostic Device Evaluation and Safety |
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Term
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Definition
| Office of Medical Policy CDER |
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Term
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Definition
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Term
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Definition
| (FDA) Office of Regulatory Affairs |
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Term
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Definition
| Office of Research Integrity |
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Term
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Definition
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Term
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Definition
| Office of Training and Communications CDER |
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Term
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Definition
| Promotion and Advertising |
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Term
|
Definition
| Product Development Protocol |
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Term
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Definition
| Prescription Drug User Fee Act of 1992 |
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Term
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Definition
| Program Enforcement Branch |
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Term
|
Definition
| Principal Investigator (in reference to Public Health Service grant recipient) |
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Term
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Definition
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Term
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Definition
| Premarket Approval Application |
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Term
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Definition
| Pharmaceutical and Medical Device Agency (Japan) |
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Term
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Definition
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Term
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Definition
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Term
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Definition
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Term
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Definition
| Qualified Investigator (Canada) |
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Term
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Definition
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Term
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Definition
| Quality System Regulation (GMP for devices) |
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Term
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Definition
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Term
|
Definition
| Regulatory Affairs Professionals Society |
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Term
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Definition
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Term
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Definition
| Risk Evaluation and Mitigation Strategy |
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Term
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Definition
| Regulation Identifier Number (in Unified Agenda) or Regulatory Information Number (FR Vol. 71 No. 240 75148) |
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Term
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Definition
| Suspected Adverse Drug Reaction |
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Term
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Definition
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Term
|
Definition
| Small Business Representative (ORA) |
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Term
|
Definition
| Special Investigations Branch (CDRH) |
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Term
|
Definition
| Site Management Organization |
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Term
|
Definition
| Society of Clinical Research Associates |
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Term
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Definition
| Written Procedures, Standard Operating Procedures |
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Term
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Definition
| Special Protocol Assessment |
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Term
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Definition
| Significant Risk (Device) |
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Term
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Definition
| Summary of Safety and Effectiveness Data |
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Term
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Definition
| The Federal Food, Drug, and Cosmetic Act |
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Term
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Definition
| Therapeutic Products Directorate of Health Canada |
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Term
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Definition
| Unanticipated Adverse Device Effect |
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Term
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Definition
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Term
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Definition
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Term
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Definition
| Voluntaiy Action indicated (FDA inspection classification) |
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Term
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Definition
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