Abstract
Unlabeled (also called off-label) uses are defined as the use of a drug product for indications or in patient populations, doses, or routes of administration that are not included in Food and Drug Administration (FDA)-approved labeling. The prevalence and clinical importance of prescribing FDA-approved drugs for unlabeled uses is substantial. In this report, the American Medical Association's (AMA) Council on Scientific Affairs reviews and makes recommendations on four important subjects related to unlabeled uses: clinical significance and prescribing; coverage and reimbursement; dissemination of information by pharmaceutical manufacturers; and improving the Supplemental New-Drug Application (SNDA) process. The recommendations in this report have been adopted as official policy of the AMA.
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