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GUIDANCE DOCUMENT

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

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2008-D-0253
Issued by:
Guidance Issuing Office
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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.”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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0253.