FDA Issues Draft Guidance, Requests Public Comments on Communication of Off-Label Information

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The U.S. Food and Drug Administration is evaluating its policies regarding the communication of off-label information for drugs, biologics and devices, with the issuance of a draft guidance and the opening of a docket for public comments. In this newsletter, the authors summarize the agency’s draft guidance and request for public comments, and identify some key implications of these documents.

On December 27, 2011, the U.S. Food and Drug Administration (FDA) published a long-awaited draft guidance entitled Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. The draft guidance, which is open for comment until March 29, 2012, is intended to clarify the agency’s policies regarding the manner in which a manufacturer or distributor of an FDA-approved product may respond to an unsolicited request for information regarding off-label use(s).

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