Advertising, Marketing & Promotions Alert: FDA Issues Draft Guidance on Responding to Unsolicited Requests for Off-Label Information


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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Published In: Communications & Media Updates, Health Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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