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Harvard Conference to Focus on Information Issues

In its first two years, the Medical Device Regulatory, Reimbursement, and Compliance Congress at Harvard has devoted tracks to reimbursement and to fraud and abuse, and it will do so again this year. But a different angle for the conference is a track on the challenges of disseminating information about medical devices. This has become an extremely important, yet often overlooked, issue in recent years. How much information is appropriate for a device company to give to doctors?

A number of firms have gotten in trouble for getting this answer wrong. And yet, the landscape may be changing, as a new FDA draft guidance contains a provision that would allow, for the first time, device companies to disseminate peer-reviewed studies of off-label uses.   The agenda for the track covers everything from what physicians want to hear to what device companies want to say (especially concerning off-label claims) to what the role of FDA should be for dissemination issues. After all the issues are aired, three lawyers with life sciences-oriented practices will advise attendees on how to put in place processes and controls for dissemination of information. MD&DI is one of the publication sponsors of the event, which will be held March 26-28 on the Harvard campus in Cambridge, MA.

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