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 And yet, the landscape may be changing, as a new FDA draft guidance contains a provision that would allow, for the first time, device companies to disseminate peer-reviewed studies of off-label uses.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.
