FDA recently released updated draft guidance on how to explain risks to consumers in advertisements and labeling for prescription drugs, particularly the "consumer brief summary." In the draft guidance, FDA noted concern that consumers are overwhelmed by how risks are currently presented and encouraged the use of "fact boxes" written in "consumer friendly language" instead of long lists of potential side effects. FDA also called for sponsors to more directly state who should not use the advertised product, rather than issuing vague warnings or contraindications
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
