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# DTC Ad Efficacy and Risk Info Guidance
- URL: https://www.fdaweb.com/dtc-ad-efficacy-and-risk-info-guidance/
- Published: 2018-10-16T12:00:00.000Z
- Updated: 2026-09-15T00:38:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142594

FDA has issued a draft guidance, *Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements*, covering human drugs and biological products and prescription animal drugs and in DTC promotional materials for over-the-counter animal drugs. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM623515.pdf?ref=fdaweb.com) says quantitative efficacy and risk information refers to information that numerically addresses the likelihood or magnitude of a drug’s effectiveness or risks.

The guidance covers these topics: 

- 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 or risk information; and
- providing quantitative efficacy or risk information for the treatment group and the control group.