Presenting Risk Information in Prescription Drug and Medical Device Promotion May 2009

GUIDANCE DOCUMENT

• Docket Number: FDA-2008-D-0253
• Issued by: Center for Veterinary Medicine; Center for Drug Evaluation and Research; Center for Devices and Radiological Health; Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.” This guidance responds to stakeholder requests for specific guidance on how FDA evaluates prescription drug and device promotional pieces to determine whether they adequately present risk information. The guidance describes and discusses the factors FDA considers when evaluating prescription drug advertisements (ads), restricted device ads, and prescription drug and device promotional labeling for their compliance with the Federal Food, Drug, and Cosmetic Act (the act) and relevant regulations. The guidance gives examples to illustrate FDA's thinking on these factors and is intended to help regulated industry gain a better understanding of what they should consider as they develop the content and format of their promotional communications.

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