ARTICLE
16 February 2015

FDA Revises Draft Guidance On Drug Promotional Materials

JD
Jones Day

Contributor

Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
FDA recently released updated draft guidance on how to explain risks to consumers in advertisements and labeling for prescription drugs, particularly the "consumer brief summary."
United States Food, Drugs, Healthcare, Life Sciences

FDA recently released updated draft guidance on how to explain risks to consumers in advertisements and labeling for prescription drugs, particularly the "consumer brief summary." In the draft guidance, FDA noted concern that consumers are overwhelmed by how risks are currently presented and encouraged the use of "fact boxes" written in "consumer friendly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.

See More Popular Content From

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More