• FDA Issues Draft Guidance for Review of DTC Television Ads
  • March 20, 2012 | Authors: Heather D. Banuelos; Gary C. Messplay
  • Law Firm: Hunton & Williams LLP - Washington Office
  • On March 12, 2012, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance titled “Direct-to-Consumer Television Advertisements—FDAAA DTC Television Ad PreDissemination Review Program.” The draft guidance explains how FDA plans to implement the requirement for the pre-dissemination review of direct-to-consumer television advertisements (“DTC TV ads”) according to Section 503B of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). Comments on the draft guidance should be submitted by May 14, 2012, to be considered for any final version of the guidance.