Biomaterial Database

Improving the Food and Drug Administration's mandate to ensure postmarketing drug safety. 2011

Dima M Qato, and G Caleb Alexander

Section of General Internal Medicine, Department of Medicine, University of Chicago Hospitals, Chicago, Illinois, USA.

UI	MeSH Term	Description	Entries
D011358	Product Surveillance, Postmarketing	Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.	Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D003142	Communication	The exchange or transmission of ideas, attitudes, or beliefs between individuals or groups.	Miscommunication,Misinformation,Social Communication,Communication Programs,Communications Personnel,Personal Communication,Communication Program,Communication, Personal,Communication, Social,Communications, Social,Miscommunications,Misinformations,Personnel, Communications,Program, Communication,Programs, Communication,Social Communications
D004345	Drug Industry	That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.	Industries, Pharmaceutic,Industry, Drug,Industry, Pharmaceutic,Industry, Pharmaceutical,Pharmaceutical Industry,Drug Industries,Industries, Drug,Industries, Pharmaceutical,Pharmaceutic Industries,Pharmaceutic Industry,Pharmaceutical Industries
D004348	Drug Labeling	Use of written, printed, or graphic materials upon or accompanying a drug container or wrapper. It includes contents, indications, effects, dosages, routes, methods, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions, and other relevant information.	Labeling, Drug,Package Inserts, Drug,Product Labeling, Drug,Black Box Warning,Boxed Warning,Drug Labelling,Black Box Warnings,Box Warning, Black,Box Warnings, Black,Boxed Warnings,Drug Package Insert,Drug Package Inserts,Drug Product Labeling,Insert, Drug Package,Inserts, Drug Package,Labeling, Drug Product,Labelling, Drug,Package Insert, Drug,Warning, Black Box,Warning, Boxed,Warnings, Black Box,Warnings, Boxed
D012449	Safety	Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.	Safeties
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014486	United States Food and Drug Administration	An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.	Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration
D018570	Risk Assessment	The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988)	Assessment, Risk,Benefit-Risk Assessment,Risk Analysis,Risk-Benefit Assessment,Health Risk Assessment,Risks and Benefits,Analysis, Risk,Assessment, Benefit-Risk,Assessment, Health Risk,Assessment, Risk-Benefit,Benefit Risk Assessment,Benefit-Risk Assessments,Benefits and Risks,Health Risk Assessments,Risk Analyses,Risk Assessment, Health,Risk Assessments,Risk Benefit Assessment,Risk-Benefit Assessments
D064420	Drug-Related Side Effects and Adverse Reactions	Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.	Drug-Related Side Effects and Adverse Reaction,Adverse Drug Event,Adverse Drug Reaction,Drug Side Effects,Drug Toxicity,Side Effects of Drugs,Toxicity, Drug,Adverse Drug Events,Adverse Drug Reactions,Drug Event, Adverse,Drug Events, Adverse,Drug Reaction, Adverse,Drug Reactions, Adverse,Drug Related Side Effects and Adverse Reaction,Drug Related Side Effects and Adverse Reactions,Drug Side Effect,Drug Toxicities,Effects, Drug Side,Reactions, Adverse Drug,Side Effect, Drug,Side Effects, Drug,Toxicities, Drug