This guidance provides recommendations for presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements for prescription human drug and biological products and prescription animal drugs and in DTC promotional labeling for over-the-counter animal drugs (collectively, promotional communications). For the purposes of this guidance, quantitative efficacy and risk information refers to information that numerically addresses the likelihood or magnitude of a drug’s efficacy or risks. The guidance outlines FDA’s recommendations for how firms that include quantitative efficacy or risk information in DTC promotional communications for their drugs can make the language and presentation more consumer-friendly. The guidance covers the following topics: (1) Providing quantitative efficacy or risk information for the control group, when applicable (2) Presenting probability information in terms of absolute frequencies, percentages, and relative frequencies (3) Formatting quantitative efficacy or risk information (4) Using visual aids to illustrate quantitative efficacy or risk information In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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