- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Foods and Veterinary Medicine, Center for Veterinary MedicineOffice of Medical Products and Tobacco, Center for Drug Evaluation and ResearchOffice of Medical Products and Tobacco, Center for Biologics Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” The guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including prescription biological products, and for animal prescription drugs. This guidance finalizes the revised draft guidance issued on November 20, 2013 (“Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling”).
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:
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.