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Direct-to-Consumer Promotional Labeling

FDA Issues Final Guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertising

[09/08/23]

Posted on September 8, 2023 in Health Law News

Published by: Hall Render

On June 27, 2023, the Food and Drug Administration (“FDA”) issued its Final Guidance for the presentation of “Quantitative Efficacy and Risk Information” in Direct-to-Consumer (“DTC”) promotional labeling and advertisements for prescription drug and biological products, prescription animal drugs and DTC promotional labeling for over-the-counter animal drugs. The Final Guidance provides recommendations on how... READ MORE

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