FDA Guidance on Product Name Placement in Advertising and Promotional Labeling

The FDA released a guidance document entitled ‘‘Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling’’ on January 25, 2012. The guidance is intended to clarify for applicants the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertising for prescription human and animal drugs and biological products. The guidance finalizes the draft guidance published in January 1999. Comments on FDA guidance documents may be submitted at any time.

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