Journal Reprint Guidance: Industry And FDA Still At Odds Over Off-Label Information
This article was originally published in The Pink Sheet Daily
PhRMA says FDA’s revised draft guidance on reprints should recognize the benefits of off-label prescribing and allow communications beyond “adequate and well-controlled” clinical studies.
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Agency grants two citizen petitions from a coalition of pharma companies requesting greater clarity from FDA, but whether the forthcoming guidances will satisfy industry remains an open question.
Republicans on the Senate HELP Committee say they are concerned that FDA is using draft guidance documents to set substantive policy, which they argue puts companies in a difficult position.
FDA has revised, but not loosened, its 2009 final guidance on good reprint practices for distribution of journal articles on unapproved uses of approved drugs and devices.