The US Food and Drug Administration (FDA) has published final guidance on presenting risk and efficacy for direct-to-consumer (DTC) promotional labeling and advertisements for prescription drug and biologic products for humans and drug products for animals.
The aim of the final guidance is to provide recommendations for companies on how to create advertisements and promotional materials for DTC drug and biologic products with “consumer-friendly” language and presentation, which includes information on presenting probability, formatting quantitative efficacy and risk information, and use of visual aids.
FDA’s guidance, which finalizes a draft guidance released by the agency in October 2018 under the same name, adds “clarifying considerations for quantitative efficacy or risk presentations across various media types” as well as further explanation in examples from the draft guidance and the addition of organizational and editorial changes to the text…
