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Keep Limits On Off-Label Promotion, Consumers And Patients Say

 
• By Sue Sutter

Prescribers can get information they need through continuing education programs and scientific conferences, non-industry stakeholders tell US FDA during second day of meeting on manufacturer communications for unapproved uses.

Continuing medical education, professional meetings and scientific conferences are adequate mechanisms by which drug manufacturers can share data about unapproved uses, consumer advocates and academic researchers said Nov. 10 in arguing against any relaxation of FDA restrictions on off-label communications.

During the second day of a two-day FDA hearing, agency officials listened to more than two dozen individuals, the majority of whom suggested that allowing more communications about off-label use...

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