FDA Policy/General

DTC Ad Efficacy and Risk Info Guidance

David McFarland

— 1 min read
Share

FDA has issued a draft guidance, Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements, covering human drugs and biological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 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.

Read more