Definitions
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Examples
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Off-label usage precedes formal FDA approval because the approval process is so expensive and slow.
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Off-label use of NovoSeven has previously raised concerns, partly because a drug that promotes formation of clots can increase risk of heart attacks and strokes.
Off-Label Use of Clot Drug Is Faulted Ron Winslow 2011
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Off-label usage helps American patients because they get what their physicians believe are the best available drugs for their conditions.
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Off-label use is allowed when doctors can prove they understand the risks and benefits of a drug when used to treat diseases outside the realm that is covered by the approval of the U.S. Food and Drug Administration.
U.K. Deals Blow to Roche, Novartis Goran Mijuk 2011
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Off-label promotion of drugs has become one of the most controversial issues in the pharmaceutical industry, and has led to a host of federal indictments and massive settlements.
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"Off-label" use of existing drugs to expand their market share, though there may be little or no research that justifies such use.
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Off-label prescribing is controversial with regulators and some politicians, who view it as a way to shortcut clinical testing and skirt the FDA approval process.
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"Off-label" use of existing drugs to expand their market share, though there may be little or no research that justifies such use.
Dr. Andrew Weil: Disease Mongering: Good For Big Pharma, Bad For You Dr. Andrew Weil 2010
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Off-label prescribing is controversial with regulators and some politicians, who view it as a way to shortcut clinical testing and skirt the FDA approval process.
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"Off-label" use of existing drugs to expand their market share, though there may be little or no research that justifies such use.
Dr. Andrew Weil: Disease Mongering: Good For Big Pharma, Bad For You 2010
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