Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices

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The Food and Drug Administration (FDA) is issuing final regulations pertaining to the dissemination of information on unapproved uses (also referred to as ``new uses'' and ``off-label uses'') for marketed drugs, including biologics, and devices. The final rule describes the new use information that a manufacturer may disseminate and describes the content of and establishes procedures for a manufacturer's submission to FDA before it may begin disseminating information on the new use. The final rule also describes how manufacturers seeking to disseminate information on a new use must agree to submit a supplemental application for that use within a specified period of time, unless a supplemental application already has been submitted or FDA has exempted the manufacturer from the requirement to submit a supplement. The final rule provides for requests to extend the time period for submitting a supplemental application for a new use and describes how a manufacturer can seek an exemption from the requirement to submit a supplemental application for the new use. Additionally, the final rule discusses FDA actions in response to manufacturers' submissions, corrective actions that FDA may ta