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Individual differences |
Methods | Statistics | Clinical | Educational | Industrial | Professional items | World psychology |
In the United States, indications for medications are strictly regulated by the Food and Drug Administration (FDA), which includes them in the package insert under the phrase "Indications and Usage". Most countries and jurisdictions have a licensing body whose duty it is to determine whether to approve a drug for a specific indication, based on the relative safety of the drug and its efficacy for the particular usage being investigated. The EMA holds this responsibility for the whole of the European Union.
If a drug is prescribed or taken for a reason other than one of its approved indications, such use can be termed off-label.
There are different classes of indication of drugs depending on validity of the benefit gained by the use of specific drug. As the consensus to use the drug increases its class of indication is improved.