Advertising, Marketing & Promotions Alert: FDA Issues Draft Guidance on Responding to Unsolicited Requests for Off-Label Information

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On December 27, 2011, the Food and Drug Administration (FDA) released its draft “Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” the first of multiple planned draft guidances responding to testimony and comments from 2009 hearings addressing social media marketing by manufacturers and distributors (companies) of prescription human and animal drug products and medical devices.

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