• New FDA Draft Guidance on DTC Television Advertisements

    The US Food and Drug Administration (FDA) released new draft guidance 12 March on how FDA intends to review TV advertisements before they are disseminated to the public. Guidance for Industry - Direct-to-Consumer Television Advertisements - FDAAA DTC Television Ad Pre-Dissemination Review Program "describes the types of TV ads that FDA intends to be subject to this provision, explains how FDA will notify sponsors that an ad is subject to the requirement of review under...
  • FDA Plans Study on Corrective DTC Advertising

    The US Food and Drug Administration (FDA) is calling for a study on corrective direct-to-consumer (DTC) advertising and its impact on correcting misperceptions about a product's safety and efficacy for a given indication. "FDA regulations require prescription drug advertisements to contain accurate information about the benefits and risks of the drug advertised.  When this is not the case, corrective advertising is designed to dissipate or correct erroneous belief...
  • FDA Releases Study on Major Statements in DTC Advertising, Reopens Comment Period on Proposed DTC Regulation

    The US Food and Drug Administration (FDA) released the results of a new study on 27 January that explores the impact of distraction on a consumer's understanding of important information in direct-to-consumer (DTC) television advertising. The study , Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements , was conducted in response to a proposed...