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# Guide on DTC Quantitative Efficacy/Risk Info
- URL: https://www.fdaweb.com/guide-on-dtc-quantitative-efficacy-risk-info/
- Published: 2023-12-11T12:00:00.000Z
- Updated: 2026-09-14T14:18:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155960

FDA has issued a revised final guidance entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.” The document provides recommendations for presenting information that is described as numerically addressing the likelihood or magnitude of a drug’s efficacy or risks. It also outlines how firms that include quantitative efficacy/risk information in DTC communications can make the language/presentation more consumer-friendly. It covers the following topics:

- 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
- Using visual aids to illustrate quantitative efficacy/risk information