FDA Issues Guidance On Off-Label Info; Waxman Seeks ‘Re-examination’
This article was originally published in The Pink Sheet Daily
The guidance supports long-standing policy on scientifically sound journal articles and imparts no new freedoms, device industry organization AdvaMed says.
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The device industry wants more protection than that supplied in draft FDA guidance on appropriate dissemination of journal articles for studies of non-approved product uses, while some members of Congress believe distribution of off-label study information should be banned outright
Rep. Henry Waxman, chair of the House Committee on Oversight and Government Reform, is urging FDA not to go forward with a guidance that he says would allow companies to use journal articles to promote off-label uses of devices and drugs
FDA has at least 16 projects under way to improve its information technology systems and infrastructure, but no comprehensive IT strategic plan to coordinate and manage the efforts, according to the Government Accountability Office