Newly-issued final guidance focuses on language used when communicating quantitative efficacy or risk information.
The FDA has issued its final guidance “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.” The draft guidance was issued in October 2018.
This final guidance provides recommendations for manufacturers, distributors, and packers when presenting quantitative efficacy and risk information in DTC promotional labeling and advertisements for prescription human drug and biological products, as well as prescription and over-the-counter animal drugs.
The recommendations, the FDA says, are based on current research related to communicating health information and cover the following topics:
- Providing quantitative efficacy or risk information from the control group, when applicable;
- Presenting probability information in terms of absolute frequencies, percentages, and relative frequencies;
- Formatting quantitative efficacy or risk information; and
- Using visual aids to illustrate quantitative efficacy or risk information.
Reference: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements, June 27, 2023. FDA website.
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