Requests for journal articles on off-label uses can be filled by device firms -- FDA.
This article was originally published in The Gray Sheet
Executive SummaryJOURNAL ARTICLES ON OFF-LABEL DEVICE USES: UNSOLICITED REQUESTS for the articles can be filled by manufacturers as long as they document the activity, Byron Tart, head of the promotion and advertising policy staff in the device center's Office of Compliance, told attendees at a Food and Drug Law Institute conference Sept. 7 in Washington, D.C. FDA's Center for Devices and Radiological Health plans to send a letter to manufacturers in the next few months informing them of the policy change.
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