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GUIDANCE DOCUMENT

Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final December 2017

Final
Docket Number:
FDA-1999-D-4079
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Veterinary Medicine

This guidance clarifies the requirements for product name placement, size, prominence, and frequency2 in promotional labeling and advertisements for prescription drugs.3 The disclosure of the product name in promotional labeling and advertisements is important for proper identification and to ensure safe and effective use. This guidance also articulates the circumstances under which FDA intends to refrain from taking enforcement action regarding these requirements. We believe that following this guidance will allow for appropriate advertising and promotion without presenting any public health risk to patients.


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-1999-D-4079.