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Regulatory Focus™ > News Articles > FDA Issues Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medica

FDA Issues Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion

Posted 01 November 2009

Recently, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion, which describes factors FDA intends to consider when evaluating risk information for advertisements and promotional labeling of prescription drugs and restricted medical devices,1 and promotional labeling for all medical devices.2 The draft guidance provides recommendations on how to comply with FDA's requirements to ensure the presentation of truthful product information, and advises companies to use a balanced approach in conveying the benefits and the risks of a particular product. While not legally binding on FDA or the pharmaceutical or device industries, the draft guidance summarizes the agency's current thinking and recommendations on presenting risk information.

 

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