FDA proposes off-label usage guidelines
FDA proposes off-label usage guidelines
Born out of the 1997 FDA Modernization Act, the U.S. Food and Drug Administration has finalized a draft proposal of guidelines that frames the overall loosening of the ability for drug makers to put out off-label usage. In essence, only unabridged peer-reviewed journal articles can be sent to health care prof essionals, along with product labeling information and a bibliography of other journal references.
Financial, ethical exemptions available
Information from a different manufacturer cannot be included without permission, while disclosures of any financial interest among authors and whether other drugs have the same off-label capabilities also must be included.
That done, pharmaceutical companies must submit the material to the FDA 60 days before publication, and the process must be couched in terms of the company making an effort to gain approval for a new indication.
Toward that end, drug makers can submit a new-use application, certify that required clinical studies have been completed and an application will be filed within six months, offer a protocol schedule promising application in 36 months, or pursue an exemption based on financial or ethical provisions.
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