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# DTC Efficacy and Risk Information Guidance
- URL: https://www.fdaweb.com/dtc-efficacy-and-risk-information-guidance/
- Published: 2023-06-27T12:00:00.000Z
- Updated: 2026-09-14T18:41:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154774

FDA has published a guidance, *Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements*, with recommendations for presenting the cited information in promotional labeling and ads for prescription human drug and biological products, prescription animal drugs, and in DTC promotional labeling for over-the-counter animal drugs. The [document](https://www.fda.gov/media/169803/download?ref=fdaweb.com) says it outlines agency recommendations for how firms that include quantitative efficacy or risk information in DTC promotional communications can make the language and presentation more consumer-friendly. The guidance covers:

- providing quantitative efficacy or risk information for 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.